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FDA 510(k)

BreathID® Smart System

K-Number: K223185 · 2022-11-10

ApplicantMeridian Bioscience Israel , Ltd.
Decision Date2022-11-10
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BreathID® Smart System is a medical device manufactured by Meridian Bioscience Israel , Ltd.. It received FDA 510(k) clearance on 2022-11-10 under approval number K223185. 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 2022-11-10. It is manufactured by Meridian Bioscience Israel , Ltd.. The 510(k) number is K223185.

When was BreathID® Smart System approved by the FDA?

BreathID® Smart System received FDA 510(k) clearance on 2022-11-10, under approval number K223185.

What company makes BreathID® Smart System?

BreathID® Smart System is manufactured by Meridian Bioscience Israel , Ltd..

What is the FDA product code for BreathID® Smart System?

The FDA product code for BreathID® Smart System is MSQ.

Related Clinical Trials

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Other Devices by Meridian Bioscience Israel , Ltd.

K221896BreathID Hp System K220494BreathID Hp Lab System, BreathID Smart System

Related Devices (Code: MSQ)

K162150BreathID Hp Lab SystemExalenz Bioscience , Ltd. K173777BreathID Hp Lab SystemExalenz Bioscience , Ltd. K173772BreathID Hp SystemExalenz Bioscience , Ltd. K193610BreathID Smart SystemExalenz Bioscience , Ltd. K221896BreathID Hp 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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