FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
CARIEL F12
K Number: K823934
·
Decision Dec 16, 1983
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
6
Review Days
352
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Basic Information
- Device Name
- CARIEL F12
- K Number
- K823934
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Odam
- Date Received
- December 29, 1982
- Decision Date
- December 16, 1983
- Product Code
- DYC
- 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 |
|---|---|---|---|
| DYC | Vectorcardiograph | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DYC), ordered by most recent decision date.
MIDA ALGORITHM REV. B
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MIDA SYSTEM, MODELS 1000/1100
FDA 510(k)
FDA Class 2
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DIRECT WRITING VECTORCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Odam
| K Number | Device Name | ||
|---|---|---|---|
| K972535 | MAGLIFE C | Jan 13, 1998 | Substantially Equivalent |
| K950264 | MAGLIFE | Sep 27, 1996 | Substantially Equivalent |
| K854175 | DEFIGARD 2000 | Jan 13, 1986 | Substantially Equivalent |
| K823931 | DEFIGARD M(OR DEFISCOPE M | Apr 12, 1983 | Substantially Equivalent |
| K823933 | MINIDEF (OR DEFIPORT | Apr 12, 1983 | Substantially Equivalent |