Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BreathID Hp Lab System, BreathID Smart System

K-Number: K220494 · 2022-06-23

Decision Date2022-06-23
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BreathID Hp Lab System, 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 2022-06-23 under 510(k) number K220494. 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 Hp Lab System, BreathID Smart System?

BreathID Hp Lab System, BreathID Smart System is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is Meridian Bioscience Israel , Ltd.. The 510(k) number is K220494.

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

BreathID Hp Lab System, BreathID Smart System received FDA 510(k) clearance on 2022-06-23, under 510(k) number K220494.

Who is the listed applicant for BreathID Hp Lab System, 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 Hp Lab System, BreathID Smart System?

The FDA product code for BreathID Hp Lab System, 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.

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.

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.