Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

ApplicantMeridian Bioscience Israel , Ltd.
Decision Date2022-06-23
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BreathID Hp Lab System, BreathID Smart System is a medical device manufactured by Meridian Bioscience Israel , Ltd.. It received FDA 510(k) clearance on 2022-06-23 under approval 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. It is manufactured by Meridian Bioscience Israel , Ltd.. The 510(k) number is K220494.

When was BreathID Hp Lab System, BreathID Smart System approved by the FDA?

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

What company makes BreathID Hp Lab System, BreathID Smart System?

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

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.

Related Clinical Trials

NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT07579832 Quantitative Monitoring of Disability Care Quality for Long-Term Care Facilities 2 NOT_YET_RECRUITING NCT06657183 ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy RECRUITING NCT07574229 Support System Design for Adolescent Scoliosis Orthosis Wear RECRUITING NCT07573540 Optimizing Smart Technology for Addiction Recovery NOT_YET_RECRUITING NCT03505801 Confirm Rx Insertable Cardiac Monitor SMART Registry COMPLETED

Other Devices by Meridian Bioscience Israel , Ltd.

K221896BreathID Hp System K223185BreathID® 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. K223185BreathID® 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.

↑