SleepImage System— 510(k) K163696

Name: FDA 510(k) clearance K163696
Creator: U.S. Food and Drug Administration
Published: 2017-10-13

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.. Device class: 2.

Clearance details

Applicant: Mycardio, LLC Dba Sleepimage.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2016-12-29
Decision date: 2017-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomfield, CO, US

Download summary PDF View on FDA.gov ↗

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