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FDA 510(k)

EARLYSENSE ES-16 SYSTEM

K-Number: K070375 · 2007-11-15

ApplicantEarlysense, Ltd.
Decision Date2007-11-15
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EARLYSENSE ES-16 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Earlysense, Ltd.. It received FDA 510(k) clearance on 2007-11-15 under 510(k) number K070375. 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 ES-16 SYSTEM?

EARLYSENSE ES-16 SYSTEM is a medical device that received FDA 510(k) clearance on 2007-11-15. The listed applicant is Earlysense, Ltd.. The 510(k) number is K070375.

When did EARLYSENSE ES-16 SYSTEM receive FDA 510(k) clearance?

EARLYSENSE ES-16 SYSTEM received FDA 510(k) clearance on 2007-11-15, under 510(k) number K070375.

Who is the listed applicant for EARLYSENSE ES-16 SYSTEM?

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 ES-16 SYSTEM?

The FDA product code for EARLYSENSE ES-16 SYSTEM is BZQ.

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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 UnitK152911EarlySense Insight SytemK131379EARLYSENSEK121885EARLYSENSE CENTRAL DISPLAY SYSTEMK120465EARLYSENSE (EVERON) SYSTEMK110521EVERON CENTRAL DISPLAY STATION (CDS)

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Related Devices (Code: BZQ)

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.

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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.

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