EARLYSENSE— 510(k) K131379

Substantially Equivalent

Earlysense, Ltd.

FDA 510(k) clearance K131379 for EARLYSENSE, Substantially Equivalent on 2013-12-18. Applicant: Earlysense, Ltd..

Clearance details

Applicant: Earlysense, Ltd.
Product code: Code BZQ
Advisory panel: Anesthesiology
Date received: 2013-05-14
Decision date: 2013-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramat-Gan, IL

Download summary PDF View on FDA.gov ↗

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