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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 K141355
Device Name VOLUMETRIC INCENTIVE SPIROMETER
Applicant
BESMED HEALTH BUSINESS CORPORATION
No. 5, Lane 116, Wu-Kong 2nd Rd. Wu-ku District
New Taipei City,  TW 24888
Applicant Contact PAUL DRYDEN
Correspondent
BESMED HEALTH BUSINESS CORPORATION
No. 5, Lane 116, Wu-Kong 2nd Rd. Wu-ku District
New Taipei City,  TW 24888
Correspondent Contact PAUL DRYDEN
Regulation Number868.5690
Classification Product Code
BWF  
Date Received05/23/2014
Decision Date 09/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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