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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 K002768
Device Name ACAPELLA
Applicant
DHD HEALTHCARE CORP.
ONE MADISON ST.
WAMPSVILLE,  NY  13163
Applicant Contact LAWRENCE WEINSTEIN
Correspondent
DHD HEALTHCARE CORP.
ONE MADISON ST.
WAMPSVILLE,  NY  13163
Correspondent Contact LAWRENCE WEINSTEIN
Regulation Number868.5690
Classification Product Code
BWF  
Date Received09/06/2000
Decision Date 12/05/2000
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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