STABILET INFANT RADIANT WARMER MODEL 2000C
FDA 510(k) clearance K913945 · decided 1992-02-12
Clearance details
- K-number
- K913945
- Device name
- STABILET INFANT RADIANT WARMER MODEL 2000C
- Applicant
- Hill-Rom, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-09-04
- Decision date
- 1992-02-12
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- FMT
- Device class
- 2
- Regulation number
- 880.5130
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Batesville, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3 recall (Z-1955-2009) | Draeger Medical Systems, Inc. | 2009-08-25 |