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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K103631
Device Name SLEEPMINDER BREATHING FREQUENCY INDICATOR
Applicant
Biancamed Limited
Novaucd, Belfield Innovation P
University College Dublin
Belfield, Dublin,  IE 4
Applicant Contact PAUL PHILLIPS
Correspondent
Biancamed Limited
Novaucd, Belfield Innovation P
University College Dublin
Belfield, Dublin,  IE 4
Correspondent Contact PAUL PHILLIPS
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received12/13/2010
Decision Date 07/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT01319396
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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