BreathID Smart System— 510(k) K193610

Name: FDA 510(k) clearance K193610
Creator: U.S. Food and Drug Administration
Published: 2020-02-06

Substantially Equivalent

Exalenz Bioscience , Ltd.

FDA 510(k) clearance K193610 for BreathID Smart System, Substantially Equivalent on 2020-02-06. Applicant: Exalenz Bioscience , Ltd.. Device class: 1.

Clearance details

Applicant: Exalenz Bioscience , Ltd.
Product code: Code MSQ
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 2019-12-26
Decision date: 2020-02-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Modiin, IL

Download summary PDF View on FDA.gov ↗

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K173772 — BreathID Hp System2018-03-08
K173777 — BreathID Hp Lab System2018-03-08

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K162150 — BreathID Hp Lab System2016-10-31
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Data sourced from openFDA. This site is unofficial and independent of the FDA.