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FDA 510(k)

BreathID Smart System

K-Number: K193610 · 2020-02-06

ApplicantExalenz Bioscience , Ltd.
Decision Date2020-02-06
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BreathID Smart System is the device name listed in this FDA 510(k) record. The listed applicant is Exalenz Bioscience , Ltd.. It received FDA 510(k) clearance on 2020-02-06 under 510(k) number K193610. The device is classified under product code MSQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BreathID Smart System?

BreathID Smart System is a medical device that received FDA 510(k) clearance on 2020-02-06. The listed applicant is Exalenz Bioscience , Ltd.. The 510(k) number is K193610.

When did BreathID Smart System receive FDA 510(k) clearance?

BreathID Smart System received FDA 510(k) clearance on 2020-02-06, under 510(k) number K193610.

Who is the listed applicant for BreathID Smart System?

The FDA 510(k) record lists Exalenz Bioscience , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BreathID Smart System?

The FDA product code for BreathID Smart System is MSQ.

Other records listing Exalenz Bioscience , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173777BreathID Hp Lab SystemK173772BreathID Hp SystemK162150BreathID Hp Lab System

Related Devices (Code: MSQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221896BreathID Hp SystemMeridian Bioscience Israel , Ltd.K223185BreathID® Smart SystemMeridian Bioscience Israel , Ltd.K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel , Ltd.K173777BreathID Hp Lab SystemExalenz Bioscience , Ltd.K173772BreathID Hp SystemExalenz Bioscience , Ltd.K162150BreathID Hp Lab SystemExalenz Bioscience , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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