FDA 510(k)

SleepImage System

K-Number: K163696 · 2017-10-13

Decision Date2017-10-13

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 2017-10-13 under approval number K163696. 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 2017-10-13. It is manufactured by Mycardio, LLC Dba Sleepimage.. The 510(k) number is K163696.

When was SleepImage System approved by the FDA?

SleepImage System received FDA 510(k) clearance on 2017-10-13, under approval number K163696.

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.

Other Devices by Mycardio, LLC Dba Sleepimage.

K182618SleepImage System

Related Devices (Code: MNR)

K153070Watch-PAT200UItamar Medical , Ltd. K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/NasalSalter Labs K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc. K163665MATRx plusZephyr Sleep Technologies K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical K161579Watch-PAT200UItamar Medical , Ltd.

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.