The following data is part of a premarket notification filed by Breathe Technologies with the FDA for Breathe Technologies Life2000™ Ventilation System.
| Device ID | K170037 |
| 510k Number | K170037 |
| Device Name: | Breathe Technologies Life2000™ Ventilation System |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Breathe Technologies 175 Technology Drive, Suite 100 Irvine, CA 92618 |
| Contact | Samir Ahmad |
| Correspondent | Craig Coombs Coombs Medical Device Consulting, Inc. 1193 Sherman St Alameda, CA 94501 |
| Product Code | CBK |
| Subsequent Product Code | BTI |
| Subsequent Product Code | NOU |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-04 |
| Decision Date | 2017-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887761978201 | K170037 | 000 |
| 00887761978195 | K170037 | 000 |
| 00887761978089 | K170037 | 000 |
| 00887761974739 | K170037 | 000 |