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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 K870173
Device Name LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL
Applicant
MAUNA LOA MEDICAL, INC.
3387 CHICAGO AVE.
RIVERSIDE,  CA  92507
Applicant Contact JAMES WEIGL
Correspondent
MAUNA LOA MEDICAL, INC.
3387 CHICAGO AVE.
RIVERSIDE,  CA  92507
Correspondent Contact JAMES WEIGL
Regulation Number868.5450
Classification Product Code
BTT  
Date Received01/14/1987
Decision Date 04/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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