IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00


Device Classification Name

accessory to continuous ventilator (respirator)

510(k) Number K022062
Device Name IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
Original Applicant
IMPACT INSTRUMENTATION, INC.
27 fairfield pl.
p.o. box 508
west caldwell, 
NJ 
07006 -0508

Original Contact leslie h sherman
Regulation Number 868.5895
Classification Product Code
MOD  
Date Received 06/25/2002
Decision Date 05/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No