EARLYSENSE (EVERON) SYSTEM— 510(k) K120465

Substantially Equivalent

Earlysense, Ltd.

FDA 510(k) clearance K120465 for EARLYSENSE (EVERON) SYSTEM, Substantially Equivalent on 2012-06-08. Applicant: Earlysense, Ltd.. Device class: 2.

Clearance details

Applicant: Earlysense, Ltd.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2012-02-15
Decision date: 2012-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramat-Gan, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.