Product code ISP
- Device name
- Valve, Prosthesis
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3420
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K843855 | ERGOTEST 40 & 45 | Erich Jaeger, Inc. | 1984-11-27 |
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