510(k) K152664
- Device
- TAV System
- Applicant
- New Aera, Inc.
- 510(k) number
- K152664
- Product code
- ONZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-12-02
- Date received
- 2015-09-17
- Regulation
- 868.5895
- Classification name
- Mechanical Ventilator
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ERIC JOHANSSON
- Address
- 2400 Camino Ramon, Suite 365 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 |
|---|---|---|---|
| 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 |
| K100528 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S | Breathe Technologies, Inc. | 2010-04-23 |
| K082982 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES | Breathe Technologies, Inc. | 2009-07-20 |
Legacy Summary#
summary
FDA Review#
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