The following data is part of a premarket notification filed by Event Medical, Inc. with the FDA for Inspiration; Ventilator System, Ls Ventilator System, Infant Ventilator System And Infant Ls Ventilator System.
| Device ID | K072590 |
| 510k Number | K072590 |
| Device Name: | INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | EVENT MEDICAL, INC. 81 COLUMBIA, SUITE 101 Aliso Viejo, CA 92656 |
| Contact | Robert Lundberg |
| Correspondent | Robert Lundberg EVENT MEDICAL, INC. 81 COLUMBIA, SUITE 101 Aliso Viejo, CA 92656 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-14 |
| Decision Date | 2008-01-04 |
| Summary: | summary |