FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH
K Number: K851322
·
Decision May 16, 1985
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
14
Review Days
44
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH
- K Number
- K851322
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Parexel Intl. Corp.
- Date Received
- April 2, 1985
- Decision Date
- May 16, 1985
- Product Code
- DPS
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPS), ordered by most recent decision date.
MAC 7 Resting ECG Analysis System
FDA 510(k)
FDA Class 2
·Cardiovascular
AccurECG Analysis System (v2.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
Withings BeamO (SCT02)
FDA 510(k)
FDA Class 2
·Cardiovascular
Cardiologs Holter Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
ZBPro Diagnostic
FDA 510(k)
FDA Class 2
·Cardiovascular
Masimo W1
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Parexel Intl. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K900385 | ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE | Jul 9, 1991 | Substantially Equivalent |
| K904901 | L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC | Mar 26, 1991 | Substantially Equivalent |
| K904902 | SMA 26 TRANSDUCER | Mar 26, 1991 | Substantially Equivalent |
| K884800 | ACTA GENOS ELECTROCARDIOGRAPH | Jun 22, 1989 | Substantially Equivalent |
| K862414 | FUJI CR IMAGING PLATE | Feb 26, 1987 | Substantially Equivalent |
| K864519 | PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) | Feb 13, 1987 | Substantially Equivalent |
| K862415 | TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM | Jul 1, 1986 | Substantially Equivalent |
| K862416 | FTI 100 MEDICAL THERMAL IMAGER | Jul 1, 1986 | Substantially Equivalent |
| K853295 | EMODREN EXCHANGEABLE PLASTIC BELLOWS | Aug 20, 1985 | Substantially Equivalent |
| K853296 | EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN | Aug 15, 1985 | Substantially Equivalent |