Product Code: DSF
FDA class 1
21 CFR 870.2810
Recorder, Paper Chart
Cardiovascular
The Paper Chart Recorder is a cardiovascular documentation device used to produce a permanent hard-copy record of physiological waveforms such as ECG, blood pressure, or other signals on a continuous roll or strip of paper. It is classified as an FDA Class 1 device, representing the lowest level of regulatory concern, and is subject to general controls only. The product code is DSF and it is regulated under 21 CFR 870.2810 within the Cardiovascular medical specialty.
510(k)s
87
FEI Numbers
52
Registration Numbers
52
Unique Applicants
55
Years Active
15
Basic Information
- Product Code
- DSF
- Device Class
- FDA class 1
- Regulation Number
- 870.2810
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 87 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K910871 | EDENTEC DIGITAL CHARTER MODEL 3710 | Aug 29, 1991 | Substantially Equivalent | EDENTEC CORP. |
| K912929 | DASH IV | Aug 13, 1991 | Substantially Equivalent | ASTRO-MED, INC. |
| K905856 | MODEL 556 MONITOR | Jan 11, 1991 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K902586 | GRI LASERGRAPH(TM) ECG PAPER | Jun 22, 1990 | Substantially Equivalent | GRI MEDICAL PRODUCTS, INC. |
| K902230 | COLORADO COLOR IMAGING RECORDER | Jun 19, 1990 | Substantially Equivalent | HONEYWELL, INC. |
| K901385 | GABRIEL MEDICAL CLS THERMAL RECORDER | May 09, 1990 | Substantially Equivalent | GABRIEL MEDICAL, INC. |
| K895111 | TYPE 9541 RECORDER, PAPER CHART | Jan 26, 1990 | Substantially Equivalent | S & W MEDICO TEKNIK |
| K894922 | WR3500 AND WR3600 SERIES RECORDERS | Jan 26, 1990 | Substantially Equivalent | WESTERN GRAPHTEC |
| K894736 | MT96000 PAPER CHART RECORDER | Dec 13, 1989 | Substantially Equivalent | ASTRO-MED, INC. |
| K894607 | PAQ10 PAPER CHART RECORDER | Oct 26, 1989 | Substantially Equivalent | PROTOCOL SYSTEMS, INC. |
| K893561 | EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. | Aug 25, 1989 | Substantially Equivalent | EDENTEC CORP. |
| K885058 | CARDIOCAP(TM) DR-104 REPORTER | Jul 14, 1989 | Substantially Equivalent | DATEX DIVISION INSTRUMENTARIUM CORP. |
| K890711 | DUAL GRAPH (TM) RECORDER-MONITOR | Jun 02, 1989 | Substantially Equivalent | SOMATICS, INC. |
| K884897 | FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER | Mar 09, 1989 | Substantially Equivalent | MENNEN MEDICAL, INC. |
| K890142 | A10 ULTRASCOPE RECORDER | Feb 06, 1989 | Substantially Equivalent | EMS MEDICAL, INC. |
| K884911 | CORTRONIC SCR1000 | Jan 13, 1989 | Substantially Equivalent | CORTRONIC CORP. |
| K884388 | EDENTEC MODEL 4700 SCANNER | Jan 10, 1989 | Substantially Equivalent | EDENTEC CORP. |
| K883315 | EDENTRACE MULTI-CHARTER MODEL 3700 | Dec 28, 1988 | Substantially Equivalent | EDENTEC CORP. |
| K881831 | WS 800R THERMAL ARRAY RECORDER | Jul 14, 1988 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K881346 | LIFESTAT 1600 PRINTER | Jun 09, 1988 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K880781 | DATALOGGER CHART RECORDER | May 11, 1988 | Substantially Equivalent | AIR-SHIELDS, INC. |
| K880554 | VSM(R) R2 PAPER CHART RECORDER | May 06, 1988 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K872822 | MODEL 78576A PAPER CHART RECORDER | Nov 04, 1987 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K870538 | MODEL 192 PRINTER | Apr 23, 1987 | Substantially Equivalent | ADVANCED MEDICAL PRODUCTS, INC. |
| K870119 | FIBRE OPTIC STRIP CHART RECORDER | Apr 10, 1987 | Substantially Equivalent | APEX IMAGING CORP. |
| K870039 | IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM | Feb 12, 1987 | Substantially Equivalent | PAR MICROSYSTEMS CORP. |
| K863331 | SIREDOC 60 AND SIREDOC 220 | Oct 06, 1986 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K862596 | DR-2C (MODIFICATION) | Sep 26, 1986 | Substantially Equivalent | GENERAL DEVICES |
| K855045 | MODEL 535 NEO-TRAK RECORDER | May 16, 1986 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K854866 | LONG TERM RECORDER RAG 1200 | Apr 09, 1986 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K851625 | SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000 | Nov 19, 1985 | Substantially Equivalent | EATON MEDICAL GROUP |
| K852487 | FUKUDA DENSHI MODEL AU-5001-5003 THERMAL | Sep 19, 1985 | Substantially Equivalent | FUKUDA DENSHI USA, INC. |
| K851626 | SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE | Jun 26, 1985 | Substantially Equivalent | EATON MEDICAL GROUP |
| K851274 | OHMEDA MODEL 0001/0003 RECORDER | May 15, 1985 | Substantially Equivalent | OHMEDA MEDICAL |
| K850365 | RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE | Apr 09, 1985 | Substantially Equivalent | EATON MEDICAL GROUP |
| K850487 | NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER | Mar 29, 1985 | Substantially Equivalent | NOVAMETRIX MEDICAL SYSTEMS, INC. |
| K850146 | SIREDOC, PAPER CHART RECORDER | Feb 12, 1985 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K843836 | THERMAL GRAYSCALE RF-100 | Oct 19, 1984 | Substantially Equivalent | FUKUDA DENSHI USA, INC. |
| K833000 | I-CHANNEL RECORDER | Jun 01, 1984 | Substantially Equivalent | LITTON MEDICAL ELECTRONICS |
| K832998 | 2-CHANNEL RECORDER | Jun 01, 1984 | Substantially Equivalent | LITTON MEDICAL ELECTRONICS |
| K833656 | NARCOTRACE 40 - NT40 | May 09, 1984 | Substantially Equivalent | NARCO BIO-SYSTEMS |
| K832754 | MONITORING SYSTEM AS100-AS115 RECORD | Dec 22, 1983 | Substantially Equivalent | AIR-SHIELDS, INC. |
| K831134 | PHOENIX 60/60 PROCESSOR MODULE | Nov 07, 1983 | Substantially Equivalent | PHOENIX CORP. |
| K832012 | MEDICAL ELECTRONICS-PRINTER CLOCK | Oct 31, 1983 | Substantially Equivalent | LITTON MEDICAL ELECTRONICS |
| K830321 | VENTURE II MONITORING SYSTEM | Jun 03, 1983 | Substantially Equivalent | RAE MEDICAL CORP. |
| K830315 | DUAL CHANNEL RECORDER #78574A | Mar 31, 1983 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K822978 | MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3 | Dec 15, 1982 | Substantially Equivalent | SIEMENS CORP. |
| K823210 | MODEL 525 NEO-TRAK NEONATAL RECORDER | Nov 24, 1982 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K822983 | MINGOCARD 7 & MINGOPHONE 7 | Nov 24, 1982 | Substantially Equivalent | SIEMENS CORP. |
| K822432 | CENTURION CHART RECORDER | Nov 01, 1982 | Substantially Equivalent | CLINICAL DATA, INC. |
| K821612 | MODEL 16800 TREND RECORDER | Jul 14, 1982 | Substantially Equivalent | HEALTHDYNE, INC. |
| K821173 | EVENTMASTER 3 HOLTER EVENT SCANNER | May 18, 1982 | Substantially Equivalent | INSTRUMENTS FOR CARDIAC RESEARCH |
| K820033 | CARDIOVUE ACCESSORY CART | Jan 22, 1982 | Substantially Equivalent | DIASONICS, INC. |
| K812608 | VASCULAB #R12B | Oct 02, 1981 | Substantially Equivalent | MEDASONICS, INC. |
| K811540 | SPACELABS' SYSTEM AUTORECORDER | Aug 13, 1981 | Substantially Equivalent | SPACELABS, INC. |
| K811453 | NOVATRACER RECORDER | Jul 10, 1981 | Substantially Equivalent | NOVAMETRIX MEDICAL SYSTEMS, INC. |
| K811254 | PAPER CHART RECORDER | Jul 10, 1981 | Substantially Equivalent | AMERICAN EDWARDS LABORATORIES |
| K810169 | CENTRAL STATION CONTROLLER AC100/CE100 | Feb 25, 1981 | Substantially Equivalent | HONEYWELL, INC. |
| K810167 | SINGLE CHANNELL RECORDER AR110 | Feb 25, 1981 | Substantially Equivalent | HONEYWELL, INC. |
| K810166 | 1,2,3 CHANNELL RECORDERS (AR150,AR250,-) | Feb 25, 1981 | Substantially Equivalent | HONEYWELL, INC. |
| K803225 | ADVANCEMED EXAMINER | Jan 13, 1981 | Substantially Equivalent | AMERICAN EDWARDS LABORATORIES |
| K801830 | MODEL 9300 ELECTROCARDIOVALIDATOR | Aug 27, 1980 | Substantially Equivalent | DEL MAR AVIONICS |
| K801549 | MODEL R11 SINGLE CHANNEL CHART RECORDER | Jul 14, 1980 | Substantially Equivalent | MEDASONICS, INC. |
| K801485 | SERIES 602 CKG RECORDER (MODIFIED) | Jul 08, 1980 | Substantially Equivalent | CARDIOKINETICS, INC. |
| K800851 | SERIES 602 CKGTM RECORDER | Apr 24, 1980 | Substantially Equivalent | CARDIOKINETICS, INC. |
| K792105 | CRITIKON DUAL CHANNEL RECORDER | Oct 26, 1979 | Substantially Equivalent | CRITIKON COMPANY,LLC |
| K792099 | 50MM WRITER MODEL CVM 9529 | Oct 26, 1979 | Substantially Equivalent | C-V MONITORS CORP. |
| K790825 | LS-8 VISICORDER | May 31, 1979 | Substantially Equivalent | HONEYWELL, INC. |
| K781873 | RECORDER, STRIP CHART WITH PRINTER | Jan 05, 1979 | Substantially Equivalent | MIDWEST ANALOG & DIGITAL, INC. |
| K781867 | WRITER, GEMINI-3 | Jan 05, 1979 | Substantially Equivalent | C-V MONITORS CORP. |
| K781115 | PRINTER, DIGITAL | Oct 06, 1978 | Substantially Equivalent | OUTPUT, INC. |
| K780597 | ECG PAPER, 3 CHANNEL | Jun 28, 1978 | Substantially Equivalent | ABCO DEALERS, INC. |
| K780677 | 4600 RECORDER | May 17, 1978 | Substantially Equivalent | G & W APPLIED SCIENCE LABORATORIES |
| K780640 | DRY SILVER PROCESSOR MODEL 1226 | Apr 28, 1978 | Substantially Equivalent | HONEYWELL, INC. |
| K780245 | RECORDER, RE-100P HOT STYLUS STRIP CHART | Mar 27, 1978 | Substantially Equivalent | WATERS ASSOC., INC. |
| K780338 | MINYSTAG MN-1 | Mar 15, 1978 | Substantially Equivalent | LKB INSTRUMENTS, INC. |
| K772333 | RECORDER, PAPER, ECG | Feb 13, 1978 | Substantially Equivalent | TELECTRONICS, INC. |
| K772054 | PHYSIOLOGICAL RECORDER MODEL 740 | Nov 22, 1977 | Substantially Equivalent | DATASCOPE CORP. |
| K772052 | PHYSIOLOGICAL RECORDER MODEL 721A | Nov 22, 1977 | Substantially Equivalent | DATASCOPE CORP. |
| K772048 | SINGLE & DUAL CHANNEL RECORDER | Nov 09, 1977 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K771372 | SYSTEM II | Aug 04, 1977 | Substantially Equivalent | IREX CORP. |
| K770946 | RECORD, MODEL 702, I.L. | Jul 05, 1977 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
| K770342 | RECORDER, CHART, MODEL 5536 | Mar 01, 1977 | Substantially Equivalent | HUDSON OXYGEN THERAPY SALES CO. |
| K761077 | TREND ANALYZER | Dec 28, 1976 | Substantially Equivalent | ELDECO |
| K761055 | CALCULATOR PLOTTER (MODEL 9872A) | Dec 09, 1976 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K760676 | LIFEPAK 5 CARDIOSCOPE-RECORDER MODULE | Oct 13, 1976 | Substantially Equivalent | PHYSIO-CONTROL CORP. |
| K760539 | RECORDER (#78640A) | Sep 09, 1976 | Substantially Equivalent | HEWLETT-PACKARD CO. |
FEI Numbers
This FDA classification entry is associated with 52 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 52 registration numbers. Click on an entry to view related FDA registrations.