INSTRUMENT WARMER
FDA 510(k) clearance K925530 · decided 1993-06-18
Clearance details
- K-number
- K925530
- Device name
- INSTRUMENT WARMER
- Applicant
- Superior Healthcare Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-02
- Decision date
- 1993-06-18
- Days to decision
- 228 days
- Clearance type
- Traditional
- Product code
- FMS
- Device class
- 2
- Regulation number
- 880.5140
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Cumberland, RI, 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 |
|---|---|---|
| NATURE'S CRADLE (K970334) | Infant Advantage, Inc. | 1997-04-25 |
| VAIL 100 PEDIATRIC CRIB (K963210) | Vail Products, Inc. | 1996-11-13 |
| NATURE'S CRADLE MODEL C1500 (K960747) | Infant Advantage, Inc. | 1996-05-22 |
| STRYKER ADEL BASSINET (K960012) | Stryker Corp. | 1996-03-25 |
| NATURE'S CRADLE (K951024) | Infant Advantage, Inc. | 1995-06-05 |
| MC HEALTHCARE #CH31 CHILD'S CRIB (K950058) | Janco Consulting Services | 1995-02-10 |
| MC INFANT CARE UNIE #PP30 (K950059) | Janco Consulting Services | 1995-02-10 |
| BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B (K950051) | The Brewer Co. | 1995-02-10 |
| HEAD & FOOT END DROP PEDI-CRIB (K925817) | Pedicraft, Inc. | 1993-04-20 |
| PEDICRAGT BASSINET (K925949) | Pedicraft, Inc. | 1993-04-20 |
| NATURE'S CRADLE HM-10 (K921327) | Infant Advantage, Inc. | 1992-12-29 |
| NATURE'S CRADLE(TM) (K901763) | Infant Advantage, Inc. | 1991-03-22 |
Recalls involving this device
No recalls on record reference this clearance.