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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilatory effort recorder
510(k) Number K112102
Device Name MICHELE SLEEP SCORING SYSTEMS
Applicant
YOUNES SLEEP TECHNOLOGIES
435 ELLICE AVENUE
WINNIPEG, MANITOBA,  CA R3B 1Y6
Applicant Contact MAGDY YOUNES
Correspondent
YOUNES SLEEP TECHNOLOGIES
435 ELLICE AVENUE
WINNIPEG, MANITOBA,  CA R3B 1Y6
Correspondent Contact MAGDY YOUNES
Regulation Number868.2375
Classification Product Code
MNR  
Date Received07/22/2011
Decision Date 12/20/2011
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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