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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 K092003
Device Name CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
Applicant
MyCardio, LLC
11001 W. 120TH AVE.
SUITE 200
BROOMFIELD,  CO  80021
Applicant Contact ROBERT SCHUEPPERT
Correspondent
MyCardio, LLC
11001 W. 120TH AVE.
SUITE 200
BROOMFIELD,  CO  80021
Correspondent Contact ROBERT SCHUEPPERT
Regulation Number868.2375
Classification Product Code
MNR  
Date Received07/02/2009
Decision Date 09/30/2009
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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