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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K833974
Device Name AQUAPAK 020 HUMIDIFIER ADAPTER
Applicant
RESPIRATORY CARE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
RESPIRATORY CARE, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5450
Classification Product Code
BTT  
Date Received11/16/1983
Decision Date 12/16/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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