ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
FDA 510(k) clearance K121929 · decided 2013-01-17
Clearance details
- K-number
- K121929
- Device name
- ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
- Applicant
- Diacor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-02
- Decision date
- 2013-01-17
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- FRZ
- Device class
- 2
- Regulation number
- 880.6775
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- West Valley City, UT, 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 |
|---|---|---|
| INVALIFT (K910830) | American Invalift Corp. | 1992-06-09 |
| LCI MEDICAL INC AIR/PAL (K841728) | Lehigh Consolidated Industries | 1984-06-05 |
| CELLTRAK-B (K834585) | R&D Systems, Inc. | 1984-05-02 |
| TENDER LIFTING CARE (K840796) | Lancer Assoc. | 1984-04-20 |
Recalls involving this device
No recalls on record reference this clearance.