BreathID Smart System— 510(k) K193610

Substantially Equivalent

Exalenz Bioscience , Ltd.

FDA 510(k) clearance K193610 for BreathID Smart System, Substantially Equivalent on 2020-02-06. Applicant: Exalenz Bioscience , Ltd..

Clearance details

Applicant: Exalenz Bioscience , Ltd.
Product code: Code MSQ
Advisory panel: Microbiology
Date received: 2019-12-26
Decision date: 2020-02-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Modiin, IL

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