UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR


Device Classification Name

ventilator, continuous, facility use

510(k) Number K103318
Device Name UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
Applicant
IMPACT INSTRUMENTATION, INC.
27 fairfield pl.
p.o. box 508
west caldwell, 
NJ 
07006 -0508

Applicant Contact susan mcnevin
Correspondent
IMPACT INSTRUMENTATION, INC.
27 fairfield pl.
p.o. box 508
west caldwell, 
NJ 
07006 -0508

Correspodent Contact susan mcnevin
Regulation Number 868.5895
Classification Product Code
CBK  
Subsequent Product Code
DQA  
Date Received 11/12/2010
Decision Date 04/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls