The following data is part of a premarket notification filed by Event Medical, Inc. with the FDA for Evolution 3e Ventilator.
| Device ID | K113743 |
| 510k Number | K113743 |
| Device Name: | EVOLUTION 3E VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | EVENT MEDICAL, INC. 971 CALLE AMANECER SUITE 101 San Clemente, CA 92673 |
| Contact | Rick Waters |
| Correspondent | Rick Waters EVENT MEDICAL, INC. 971 CALLE AMANECER SUITE 101 San Clemente, CA 92673 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-20 |
| Decision Date | 2012-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B079EVL100500T1 | K113743 | 000 |
| 00860008873606 | K113743 | 000 |