FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANCEMED CCU DOCUMENTOR
K Number: K803222
·
Decision Jan 13, 1981
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
89
Review Days
25
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
- ADVANCEMED CCU DOCUMENTOR
- K Number
- K803222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- American Edwards Laboratories
- Date Received
- December 19, 1980
- Decision Date
- January 13, 1981
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSH), ordered by most recent decision date.
Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
FDA 510(k)
FDA Class 2
·Cardiovascular
VitaloJAK Clinic (Model 7100)
FDA 510(k)
FDA Class 2
·Cardiovascular
Zio® monitor (DFG0001)
FDA 510(k)
FDA Class 2
·Cardiovascular
AeviceMD
FDA 510(k)
FDA Class 2
·Cardiovascular
AT-Patch (ATP-C130/ATP-C70)
FDA 510(k)
FDA Class 2
·Cardiovascular
HiCardi+ H100
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by American Edwards Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K873485 | EDSLAB (R) OCCLUSION BALLOON CATHETER | Dec 3, 1987 | Substantially Equivalent |
| K872596 | TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 | Sep 30, 1987 | Substantially Equivalent |
| K872529 | THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 | Sep 15, 1987 | Substantially Equivalent |
| K870444 | HOMEPRO II VOLUMETRIC INFUSION PUMP | Apr 17, 1987 | Substantially Equivalent |
| K864997 | MEDTRAC VP VOLUMETRIC INFUSION PUMP | Feb 27, 1987 | Substantially Equivalent |
| K864330 | SHEAR FORCE GAUGE | Jan 6, 1987 | Substantially Equivalent |
| K862724 | VEIN VALVE CUTTER | Jan 2, 1987 | Substantially Equivalent |
| K864155 | MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS | Nov 20, 1986 | Substantially Equivalent |
| K863596 | CHIN-FOGARTY INFLATION DEVICE | Nov 20, 1986 | Substantially Equivalent |
| K863986 | XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES | Oct 31, 1986 | Substantially Equivalent |