Gili Pro BioSensor (also known as Gili BioSensor System)— 510(k) DEN200038

Name: FDA 510(k) clearance DEN200038
Creator: U.S. Food and Drug Administration
Published: 2021-04-01

Unknown

Continuse Biometrics , Ltd.

FDA 510(k) clearance DEN200038 for Gili Pro BioSensor (also known as Gili BioSensor System), Unknown on 2021-04-01. Applicant: Continuse Biometrics , Ltd.. Device class: 2.

Clearance details

Applicant: Continuse Biometrics , Ltd.
Product code: Code QOK
Device class: Class 2
Regulation: 21 CFR 870.2786
Advisory panel: Cardiovascular
Date received: 2020-06-12
Decision date: 2021-04-01
Decision: Unknown
Clearance type: Direct
Location: Tel-Aviv, IL

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