FDA 510(k)

BreathID Hp Lab System

K-Number: K173777 · 2018-03-08

Decision Date2018-03-08

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 2018-03-08 under approval number K173777. 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 2018-03-08. It is manufactured by Exalenz Bioscience , Ltd.. The 510(k) number is K173777.

When was BreathID Hp Lab System approved by the FDA?

BreathID Hp Lab System received FDA 510(k) clearance on 2018-03-08, under approval number K173777.

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.

K162150BreathID Hp Lab System K173772BreathID Hp System K193610BreathID Smart System

Related Devices (Code: MSQ)

K162150BreathID 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. K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.