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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 the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience Israel , Ltd.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) 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. The listed applicant is Meridian Bioscience Israel , Ltd.. The 510(k) number is K223185.

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

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

Who is the listed applicant for BreathID® Smart System?

The FDA 510(k) record lists Meridian Bioscience Israel , 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 Meridian Bioscience Israel , 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.

K221896BreathID Hp SystemK220494BreathID Hp Lab System, BreathID Smart 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.K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel , Ltd.K193610BreathID Smart SystemExalenz Bioscience , 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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