BreathID Hp System— 510(k) K173772

Substantially Equivalent

Exalenz Bioscience , Ltd.

FDA 510(k) clearance K173772 for BreathID Hp System, Substantially Equivalent on 2018-03-08. 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: 2017-12-12
Decision date: 2018-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Modiin, IL

Download summary PDF View on FDA.gov ↗

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K193610 — BreathID Smart System2020-02-06
K173777 — BreathID Hp Lab System2018-03-08

More clearances from Exalenz Bioscience , Ltd.

K162150 — BreathID Hp Lab System2016-10-31
K130524 — BREATHID HP SYSTEM2013-05-22

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