MODEL TI500 ISOLETTE INFANT INCUBATOR
FDA 510(k) clearance K941106 · decided 1994-06-10
Clearance details
- K-number
- K941106
- Device name
- MODEL TI500 ISOLETTE INFANT INCUBATOR
- Applicant
- Air-Shields, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-03-07
- Decision date
- 1994-06-10
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- FPL
- Device class
- 2
- Regulation number
- 880.5410
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hatboro, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., recall (Z-1051-2008) | Draeger Medical, Inc. | 2008-03-18 |