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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 K091557
Device Name LUNG FLUTE THERAPEUTIC
Applicant
Medical Acoustics
255 Great Arrow Ave. Suite 23
Buffalo,  NY  14207
Applicant Contact NICOLAAS J SMIT
Correspondent
Medical Acoustics
255 Great Arrow Ave. Suite 23
Buffalo,  NY  14207
Correspondent Contact NICOLAAS J SMIT
Regulation Number868.5690
Classification Product Code
BWF  
Date Received05/27/2009
Decision Date 01/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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