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 |