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FDA 510(k)

VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI

K-Number: K011668 · 2001-07-09

ApplicantOridion Medical 1987 , Ltd.
Decision Date2001-07-09
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI is the device name listed in this FDA 510(k) record. The listed applicant is Oridion Medical 1987 , Ltd.. It received FDA 510(k) clearance on 2001-07-09 under 510(k) number K011668. 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 VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI?

VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI is a medical device that received FDA 510(k) clearance on 2001-07-09. The listed applicant is Oridion Medical 1987 , Ltd.. The 510(k) number is K011668.

When did VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI receive FDA 510(k) clearance?

VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI received FDA 510(k) clearance on 2001-07-09, under 510(k) number K011668.

Who is the listed applicant for VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI?

The FDA 510(k) record lists Oridion Medical 1987 , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI?

The FDA product code for VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI is MSQ.

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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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