FDA 510(k)

EarlySense Insight Sytem

K-Number: K152911 · 2016-05-06

Decision Date2016-05-06

Product CodeBZQ

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

EarlySense Insight Sytem is a medical device manufactured by Earlysense, Ltd.. It received FDA 510(k) clearance on 2016-05-06 under approval number K152911. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EarlySense Insight Sytem?

EarlySense Insight Sytem is a medical device that received FDA 510(k) clearance on 2016-05-06. It is manufactured by Earlysense, Ltd.. The 510(k) number is K152911.

When was EarlySense Insight Sytem approved by the FDA?

EarlySense Insight Sytem received FDA 510(k) clearance on 2016-05-06, under approval number K152911.

What company makes EarlySense Insight Sytem?

EarlySense Insight Sytem is manufactured by Earlysense, Ltd..

What is the FDA product code for EarlySense Insight Sytem?

The FDA product code for EarlySense Insight Sytem is BZQ.

Other Devices by Earlysense, Ltd.

K171836EarlySense Bed Sensing Unit

Related Devices (Code: BZQ)

K151940Thora-3Di, Model T-01Pneumacare Limited K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor ActivationHill-Rom, Inc. K171836EarlySense Bed Sensing UnitEarlysense, Ltd. K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co. , Ltd. K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.