ENFLOW IV FLUID WARMER INSULATED STRAP
FDA 510(k) clearance K130867 · decided 2013-06-14
Clearance details
- K-number
- K130867
- Device name
- ENFLOW IV FLUID WARMER INSULATED STRAP
- Applicant
- Vital Signs, Inc., A GE Healthcare Company
- Decision
- Substantially Equivalent
- Date received
- 2013-03-28
- Decision date
- 2013-06-14
- Days to decision
- 78 days
- Clearance type
- Special
- Product code
- LGZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Totowa, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood sol recall (Z-1385-2019) | Vyaire Medical | 2019-06-26 |
| enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy wi recall (Z-1386-2019) | Vyaire Medical | 2019-06-26 |