The following data is part of a premarket notification filed by Event Medical Ltd with the FDA for Inspiration Ventilator System 5i/7i.
Device ID | K130178 |
510k Number | K130178 |
Device Name: | INSPIRATION VENTILATOR SYSTEM 5I/7I |
Classification | Ventilator, Continuous, Facility Use |
Applicant | EVENT MEDICAL LTD 971CALLE AMANECER SUITE 101 San Clemente, CA 92673 |
Contact | Rick Waters |
Correspondent | Rick Waters EVENT MEDICAL LTD 971CALLE 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 | 2013-01-25 |
Decision Date | 2013-10-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B079EVM11000103US0 | K130178 | 000 |
B079EVM11000102US0 | K130178 | 000 |
B079EVM11000101US0 | K130178 | 000 |
00860008873637 | K130178 | 000 |