INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM


Device Classification Name

ventilator, continuous, facility use

510(k) Number K072590
Device Name INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM
Applicant
EVENT MEDICAL, INC.
81 columbia, suite 101
aliso viejo, 
CA 
92656

Applicant Contact robert lundberg
Correspondent
EVENT MEDICAL, INC.
81 columbia, suite 101
aliso viejo, 
CA 
92656

Correspodent Contact robert lundberg
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 09/14/2007
Decision Date 01/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No