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 |