MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS


the company

Device Classification Name

heater, breathing system w/wo controller (not humidifier or nebulizer

510(k) Number K000697
Device Name MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
Original Applicant
ALLEGIANCE HEALTHCARE CORP.
1500 waukegan rd.- k
mcgraw park, 
IL 
60085

Original Contact sharon robbins
Regulation Number 868.5270
Classification Product Code
BZE  
Date Received 03/01/2000
Decision Date 03/30/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Special
Reviewed by Third Party No

Combination Product

No