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FDA 510(k)

BreathID Hp Lab System

K-Number: K162150 · 2016-10-31

Decision Date2016-10-31
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BreathID Hp Lab System is the device name listed in this FDA 510(k) record. The listed applicant is Exalenz Bioscience , Ltd.. It received FDA 510(k) clearance on 2016-10-31 under 510(k) 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. The listed applicant is Exalenz Bioscience , Ltd.. The 510(k) number is K162150.

When did BreathID Hp Lab System receive FDA 510(k) clearance?

BreathID Hp Lab System received FDA 510(k) clearance on 2016-10-31, under 510(k) number K162150.

Who is the listed applicant for BreathID Hp Lab System?

The FDA 510(k) record lists Exalenz Bioscience , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BreathID Hp Lab System?

The FDA product code for BreathID Hp Lab System is MSQ.

Other records listing Exalenz Bioscience , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: MSQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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