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 |