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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 K163696
Device Name SleepImage System
Applicant
MyCardio, LLC dba SleepImage.
370 Interlocken Blvd.
Suite 650
Broomfield,  CO  80021
Applicant Contact Robert Schueppert
Correspondent
MyCardio, LLC dba SleepImage.
370 Interlocken Blvd.
Suite 650
Broomfield,  CO  80021
Correspondent Contact Robert Schueppert
Regulation Number868.2375
Classification Product Code
MNR  
Date Received12/29/2016
Decision Date 10/13/2017
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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