BreathID Hp System
K-Number: K221896 · 2022-12-19
ApplicantMeridian Bioscience Israel , Ltd.
Decision Date2022-12-19
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
BreathID Hp System is a medical device manufactured by Meridian Bioscience Israel , Ltd.. It received FDA 510(k) clearance on 2022-12-19 under approval number K221896. 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 System?
BreathID Hp System is a medical device that received FDA 510(k) clearance on 2022-12-19. It is manufactured by Meridian Bioscience Israel , Ltd.. The 510(k) number is K221896.
When was BreathID Hp System approved by the FDA?
BreathID Hp System received FDA 510(k) clearance on 2022-12-19, under approval number K221896.
What company makes BreathID Hp System?
BreathID Hp System is manufactured by Meridian Bioscience Israel , Ltd..
What is the FDA product code for BreathID Hp System?
The FDA product code for BreathID Hp System is MSQ.
Other Devices by Meridian Bioscience Israel , Ltd.
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K193610BreathID Smart SystemExalenz Bioscience , Ltd.
K223185BreathID® Smart SystemMeridian Bioscience Israel , Ltd.
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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.