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 a medical device manufactured by Earlysense, Ltd.. It received FDA 510(k) clearance on 2018-01-04 under approval 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. It is manufactured by Earlysense, Ltd.. The 510(k) number is K171836.
When was EarlySense Bed Sensing Unit approved by the FDA?
EarlySense Bed Sensing Unit received FDA 510(k) clearance on 2018-01-04, under approval number K171836.
What company makes EarlySense Bed Sensing Unit?
EarlySense Bed Sensing Unit is manufactured by Earlysense, Ltd..
What is the FDA product code for EarlySense Bed Sensing Unit?
The FDA product code for EarlySense Bed Sensing Unit is BZQ.
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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.