BreathID Hp System
K-Number: K173772 · 2018-03-08
ApplicantExalenz Bioscience , Ltd.
Decision Date2018-03-08
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
BreathID Hp System is a medical device manufactured by Exalenz Bioscience , Ltd.. It received FDA 510(k) clearance on 2018-03-08 under approval number K173772. 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 2018-03-08. It is manufactured by Exalenz Bioscience , Ltd.. The 510(k) number is K173772.
When was BreathID Hp System approved by the FDA?
BreathID Hp System received FDA 510(k) clearance on 2018-03-08, under approval number K173772.
What company makes BreathID Hp System?
BreathID Hp System is manufactured by Exalenz Bioscience , Ltd..
What is the FDA product code for BreathID Hp System?
The FDA product code for BreathID Hp System is MSQ.
Other Devices by Exalenz Bioscience , Ltd.
Related Devices (Code: MSQ)
K162150BreathID Hp Lab SystemExalenz Bioscience , Ltd.
K173777BreathID Hp Lab SystemExalenz Bioscience , Ltd.
K193610BreathID Smart SystemExalenz Bioscience , Ltd.
K221896BreathID Hp SystemMeridian Bioscience Israel , Ltd.
K223185BreathID® Smart 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.