UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
FDA 510(k) clearance K103318 · decided 2011-04-07
Clearance details
- K-number
- K103318
- Device name
- UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
- Applicant
- Impact Instrumentation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-12
- Decision date
- 2011-04-07
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- West Caldwell, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ recall (Z-2152-2012) | Impact Instrumentation, Inc. | 2012-08-07 |