BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
FDA 510(k) clearance K102525 · decided 2010-12-02
Clearance details
- K-number
- K102525
- Device name
- BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
- Applicant
- Breathe Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-02
- Decision date
- 2010-12-02
- Days to decision
- 91 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
+ Add to Predicate Builder ◉ Watch Breathe Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 NIOV VENTILATION SYSTEM (K131562) | Breathe Technologies | 2014-03-06 |
| BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) (K103345) | Breathe Technologies, Inc. | 2011-02-11 |
| 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.