SleepImage System
K-Number: K182618 · 2019-08-14
ApplicantMycardio, LLC Dba Sleepimage.
Decision Date2019-08-14
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
SleepImage System is a medical device manufactured by Mycardio, LLC Dba Sleepimage.. It received FDA 510(k) clearance on 2019-08-14 under approval number K182618. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SleepImage System?
SleepImage System is a medical device that received FDA 510(k) clearance on 2019-08-14. It is manufactured by Mycardio, LLC Dba Sleepimage.. The 510(k) number is K182618.
When was SleepImage System approved by the FDA?
SleepImage System received FDA 510(k) clearance on 2019-08-14, under approval number K182618.
What company makes SleepImage System?
SleepImage System is manufactured by Mycardio, LLC Dba Sleepimage..
What is the FDA product code for SleepImage System?
The FDA product code for SleepImage System is MNR.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.