UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR


Device Classification Name

ventilator, continuous, facility use

510(k) Number K111473
Device Name UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
Applicant
IMPACT INSTRUMENTATION, INC.
27 fairfield pl.
west caldwell, 
NJ 
07006 -0508

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

Correspodent Contact susan mcnevin
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 05/27/2011
Decision Date 02/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No