STRYKER ECLIPSE WARMING STRETCHER
FDA 510(k) clearance K912237 · decided 1991-07-30
Clearance details
- K-number
- K912237
- Device name
- STRYKER ECLIPSE WARMING STRETCHER
- Applicant
- Stryker Medical
- Decision
- Substantially Equivalent
- Date received
- 1991-05-21
- Decision date
- 1991-07-30
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- DWI
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TEMP STERNUM SAW (K801914) | Temp Medical Products, Inc. | 1980-10-23 |
Recalls involving this device
No recalls on record reference this clearance.