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FDA 510(k)

EarlySense Bed Sensing Unit

K-Number: K171836 · 2018-01-04

ApplicantEarlysense, Ltd.
Decision Date2018-01-04
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EarlySense Bed Sensing Unit is the device name listed in this FDA 510(k) record. The listed applicant is Earlysense, Ltd.. It received FDA 510(k) clearance on 2018-01-04 under 510(k) number K171836. 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 Bed Sensing Unit?

EarlySense Bed Sensing Unit is a medical device that received FDA 510(k) clearance on 2018-01-04. The listed applicant is Earlysense, Ltd.. The 510(k) number is K171836.

When did EarlySense Bed Sensing Unit receive FDA 510(k) clearance?

EarlySense Bed Sensing Unit received FDA 510(k) clearance on 2018-01-04, under 510(k) number K171836.

Who is the listed applicant for EarlySense Bed Sensing Unit?

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 Bed Sensing Unit?

The FDA product code for EarlySense Bed Sensing Unit 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.

K152911EarlySense Insight Sytem

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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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