The following data is part of a premarket notification filed by New Aera, Inc. with the FDA for Tav System.
| Device ID | K152664 |
| 510k Number | K152664 |
| Device Name: | TAV System |
| Classification | Mechanical Ventilator |
| Applicant | New Aera, Inc. 2400 Camino Ramon, Suite 365 Ramon, CA 94583 |
| Contact | Eric Johansson |
| Correspondent | Paul Dryden New Aera, Inc. 2400 Camino Ramon, Suite 365 Ramon, CA 94583 |
| Product Code | ONZ |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-17 |
| Decision Date | 2016-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817131020315 | K152664 | 000 |
| 00817131020230 | K152664 | 000 |
| 00817131020247 | K152664 | 000 |
| 00817131020308 | K152664 | 000 |
| 00817131020377 | K152664 | 000 |
| 00817131020384 | K152664 | 000 |
| 00817131020339 | K152664 | 000 |
| 00817131020346 | K152664 | 000 |
| 00817131020209 | K152664 | 000 |
| 00817131020216 | K152664 | 000 |
| 00817131020254 | K152664 | 000 |
| 00817131020261 | K152664 | 000 |
| 00817131020223 | K152664 | 000 |