BreathID Hp Lab System
K-Number: K162150 · 2016-10-31
ApplicantExalenz Bioscience , Ltd.
Decision Date2016-10-31
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
BreathID Hp Lab System is a medical device manufactured by Exalenz Bioscience , Ltd.. It received FDA 510(k) clearance on 2016-10-31 under approval number K162150. 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 Hp Lab System is a medical device that received FDA 510(k) clearance on 2016-10-31. It is manufactured by Exalenz Bioscience , Ltd.. The 510(k) number is K162150.
When was BreathID Hp Lab System approved by the FDA?
BreathID Hp Lab System received FDA 510(k) clearance on 2016-10-31, under approval number K162150.
What company makes BreathID Hp Lab System?
BreathID Hp Lab System is manufactured by Exalenz Bioscience , Ltd..
What is the FDA product code for BreathID Hp Lab System?
The FDA product code for BreathID Hp Lab System is MSQ.
Other Devices by Exalenz Bioscience , 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.