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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 a medical device manufactured by Exalenz Bioscience , Ltd.. It received FDA 510(k) clearance on 2020-02-06 under approval 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. It is manufactured by Exalenz Bioscience , Ltd.. The 510(k) number is K193610.

When was BreathID Smart System approved by the FDA?

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

What company makes BreathID Smart System?

BreathID Smart System is manufactured by Exalenz Bioscience , Ltd..

What is the FDA product code for BreathID Smart System?

The FDA product code for BreathID Smart System is MSQ.

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Other Devices by Exalenz Bioscience , Ltd.

K162150BreathID Hp Lab System K173777BreathID Hp Lab System K173772BreathID Hp System

Related Devices (Code: MSQ)

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