510(k) K100528
- Device
- BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S
- Applicant
- Breathe Technologies, Inc.
- 510(k) number
- K100528
- Product code
- ONZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-04-23
- Date received
- 2010-02-24
- Regulation
- 868.5895
- Classification name
- Mechanical Ventilator
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUZON LOMMEL
- Address
- 4000 Executive Pkwy., Suite 190 San Ramon CA US 94583 94583
FDA Registration Numbers#
- 3004672275
Source Documents#
Other 510(k) Records For Product Code ONZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152664 | TAV System | New Aera, Inc. | 2016-12-02 |
| K131562 | BREATHE NIOV VENTILATION SYSTEM | Breathe Technologies | 2014-03-06 |
| K103345 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | Breathe Technologies, Inc. | 2011-02-11 |
| K102525 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | Breathe Technologies, Inc. | 2010-12-02 |
| K082982 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES | Breathe Technologies, Inc. | 2009-07-20 |