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FDA 510(k)

BREATHID HP SYSTEM

K-Number: K130524 · 2013-05-22

ApplicantExalenz Bioscience , Ltd.
Decision Date2013-05-22
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BREATHID HP 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 2013-05-22 under 510(k) number K130524. 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 2013-05-22. The listed applicant is Exalenz Bioscience , Ltd.. The 510(k) number is K130524.

When did BREATHID HP SYSTEM receive FDA 510(k) clearance?

BREATHID HP SYSTEM received FDA 510(k) clearance on 2013-05-22, under 510(k) number K130524.

Who is the listed applicant for BREATHID HP 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 SYSTEM?

The FDA product code for BREATHID HP SYSTEM is MSQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K193610BreathID Smart SystemK173777BreathID Hp Lab SystemK173772BreathID Hp SystemK162150BreathID Hp Lab System

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.

K221896BreathID Hp SystemMeridian Bioscience Israel , Ltd.K223185BreathID® Smart SystemMeridian Bioscience Israel , Ltd.K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel , Ltd.K193610BreathID Smart SystemExalenz Bioscience , Ltd.K173772BreathID Hp SystemExalenz Bioscience , Ltd.K173777BreathID Hp Lab SystemExalenz Bioscience , 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.

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