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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 K003146
Device Name CLINIFLO INCENTIVE SPIROMETER
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 Received10/10/2000
Decision Date 11/21/2000
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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