INFANT WARMER SYSTEM
FDA 510(k) clearance K963058 · decided 1996-10-01
Clearance details
- K-number
- K963058
- Device name
- INFANT WARMER SYSTEM
- Applicant
- Ohmeda Medical
- Decision
- Substantially Equivalent
- Date received
- 1996-08-06
- Decision date
- 1996-10-01
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- FMT
- Device class
- 2
- Regulation number
- 880.5130
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Infant Warmer System (IWS) recall (Z-2323-2017) | GE Healthcare, LLC | 2017-05-19 |