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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Oxygen
510(k) Number K802323
Device Name PEDIATRIC OXYGEN OR AEROSOL MASKS,
Applicant
Airlife, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Airlife, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5580
Classification Product Code
BYG  
Date Received09/23/1980
Decision Date 10/03/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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