TRANSWARMER
FDA 510(k) clearance K934631 · decided 1994-02-03
Clearance details
- K-number
- K934631
- Device name
- TRANSWARMER
- Applicant
- Prism Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-09-24
- Decision date
- 1994-02-03
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- IMD
- Device class
- 1
- Regulation number
- 890.5710
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: recall (Z-1397-2015) | CooperSurgical, Inc. | 2015-04-07 |