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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 K182618
FOIA Releasable 510(k) K182618
Device Name SleepImage System
Applicant
MyCardio, LLC dba SleepImage.
3513 Brighton Blvd, Suite 530
Denver,  CO  80216
Applicant Contact Robert Schueppert
Correspondent
MyCardio, LLC dba SleepImage.
3513 Brighton Blvd, Suite 530
Denver,  CO  80216
Correspondent Contact Robert Schueppert
Regulation Number868.2375
Classification Product Code
MNR  
Date Received09/24/2018
Decision Date 08/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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