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FDA 510(k)

MATRIX HOLTER SYSTEM, MODEL M12

K-Number: K051730 · 2005-09-26

ApplicantGlobal Instrumentation, LLC
Decision Date2005-09-26
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MATRIX HOLTER SYSTEM, MODEL M12 is the device name listed in this FDA 510(k) record. The listed applicant is Global Instrumentation, LLC. It received FDA 510(k) clearance on 2005-09-26 under 510(k) number K051730. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MATRIX HOLTER SYSTEM, MODEL M12?

MATRIX HOLTER SYSTEM, MODEL M12 is a medical device that received FDA 510(k) clearance on 2005-09-26. The listed applicant is Global Instrumentation, LLC. The 510(k) number is K051730.

When did MATRIX HOLTER SYSTEM, MODEL M12 receive FDA 510(k) clearance?

MATRIX HOLTER SYSTEM, MODEL M12 received FDA 510(k) clearance on 2005-09-26, under 510(k) number K051730.

Who is the listed applicant for MATRIX HOLTER SYSTEM, MODEL M12?

The FDA 510(k) record lists Global Instrumentation, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MATRIX HOLTER SYSTEM, MODEL M12?

The FDA product code for MATRIX HOLTER SYSTEM, MODEL M12 is MLO.

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Other records listing Global Instrumentation, LLC as applicant

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Related Devices (Code: MLO)

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.

K261580ZBPro Diagnostic (Version 2.0)Zbeats, Inc.K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbHK240794Frontier X PlusFourth Frontier Technologies Pvt, Ltd.K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.K193177CER-SCardiocalmK182030Faros MobileBittium Biosignals , 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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