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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K873540
Device Name AEROBICA - LUNG EXERCISER
Applicant
MBA Healthcare Products, Inc.
519 E. Genesee St.
P.O. Box 617
Fayetteville,  NY  13066
Applicant Contact STUART A BRUCE
Correspondent
MBA Healthcare Products, Inc.
519 E. Genesee St.
P.O. Box 617
Fayetteville,  NY  13066
Correspondent Contact STUART A BRUCE
Regulation Number868.5690
Classification Product Code
BWF  
Date Received09/01/1987
Decision Date 02/04/1988
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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