The following data is part of a premarket notification filed by Event Medical Ltd with the FDA for Inspiration Ventilator System.
| Device ID | K021112 |
| 510k Number | K021112 |
| Device Name: | INSPIRATION VENTILATOR SYSTEM |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | EVENT MEDICAL LTD 800 GRAND AVE. SUITE C3 Carlsbad, CA 92008 |
| Contact | Mike Griffiths |
| Correspondent | Mike Griffiths EVENT MEDICAL LTD 800 GRAND AVE. SUITE C3 Carlsbad, CA 92008 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-05 |
| Decision Date | 2002-11-22 |
| Summary: | summary |