SleepImage System— 510(k) K163696

Substantially Equivalent

Mycardio, LLC Dba Sleepimage.

FDA 510(k) clearance K163696 for SleepImage System, Substantially Equivalent on 2017-10-13. Applicant: Mycardio, LLC Dba Sleepimage..

Clearance details

Applicant: Mycardio, LLC Dba Sleepimage.
Product code: Code MNR
Advisory panel: Anesthesiology
Date received: 2016-12-29
Decision date: 2017-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomfield, CO, US

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