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FDA 510(k)

EarlySense Insight Sytem

K-Number: K152911 · 2016-05-06

ApplicantEarlysense, Ltd.
Decision Date2016-05-06
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EarlySense Insight Sytem is the device name listed in this FDA 510(k) record. The listed applicant is Earlysense, Ltd.. It received FDA 510(k) clearance on 2016-05-06 under 510(k) 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. The listed applicant is Earlysense, Ltd.. The 510(k) number is K152911.

When did EarlySense Insight Sytem receive FDA 510(k) clearance?

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

Who is the listed applicant for EarlySense Insight Sytem?

The FDA 510(k) record lists Earlysense, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EarlySense Insight Sytem?

The FDA product code for EarlySense Insight Sytem is BZQ.

Other records listing Earlysense, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171836EarlySense Bed Sensing Unit

Related Devices (Code: BZQ)

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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.

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