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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, diagnostic
510(k) Number K123896
Device Name CCS-200 SPIROMETER
Applicant
BENSON MEDICAL INSTRUMENTS CO.
310FOURTH AVE SOUTH
SUITE 5000
MINNEAPOLIS,  MN  55415
Applicant Contact DAVID MAYOU
Correspondent
BENSON MEDICAL INSTRUMENTS CO.
310FOURTH AVE SOUTH
SUITE 5000
MINNEAPOLIS,  MN  55415
Correspondent Contact DAVID MAYOU
Regulation Number868.1840
Classification Product Code
BZG  
Date Received12/18/2012
Decision Date 09/10/2013
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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