BREATHE NIOV VENTILATION SYSTEM
FDA 510(k) clearance K131562 · decided 2014-03-06
Clearance details
- K-number
- K131562
- Device name
- BREATHE NIOV VENTILATION SYSTEM
- Applicant
- Breathe Technologies
- Decision
- Substantially Equivalent
- Date received
- 2013-05-30
- Decision date
- 2014-03-06
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- ONZ
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Alameda, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TAV System (K152664) | New Aera, Inc. | 2016-12-02 |
| BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) (K103345) | Breathe Technologies, Inc. | 2011-02-11 |
| BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) (K102525) | Breathe Technologies, Inc. | 2010-12-02 |
| BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S (K100528) | Breathe Technologies, Inc. | 2010-04-23 |
| BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (K082982) | Breathe Technologies, Inc. | 2009-07-20 |
Recalls involving this device
No recalls on record reference this clearance.