CELLTRAK-B
FDA 510(k) clearance K834585 · decided 1984-05-02
Clearance details
- K-number
- K834585
- Device name
- CELLTRAK-B
- Applicant
- R&D Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-29
- Decision date
- 1984-05-02
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- FRZ
- Device class
- 2
- Regulation number
- 880.6775
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ZEPHYR 'X-SERIES PATIENT TRANSFER SLED (K121929) | Diacor, Inc. | 2013-01-17 |
| INVALIFT (K910830) | American Invalift Corp. | 1992-06-09 |
| LCI MEDICAL INC AIR/PAL (K841728) | Lehigh Consolidated Industries | 1984-06-05 |
| TENDER LIFTING CARE (K840796) | Lancer Assoc. | 1984-04-20 |
Recalls involving this device
No recalls on record reference this clearance.