INSPIRATION VENTILATOR SYSTEM


Device Classification Name

ventilator, continuous, facility use

510(k) Number K021112
Device Name INSPIRATION VENTILATOR SYSTEM
Original Applicant
EVENT MEDICAL LTD
800 grand ave.
suite c3
carlsbad, 
CA 
92008

Original Contact mike griffiths
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 04/05/2002
Decision Date 11/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No