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FDA 510(k)

M5 Recorder

K-Number: K202456 · 2020-12-29

ApplicantGlobal Instrumentation, LLC
Decision Date2020-12-29
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M5 Recorder 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 2020-12-29 under 510(k) number K202456. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M5 Recorder?

M5 Recorder is a medical device that received FDA 510(k) clearance on 2020-12-29. The listed applicant is Global Instrumentation, LLC. The 510(k) number is K202456.

When did M5 Recorder receive FDA 510(k) clearance?

M5 Recorder received FDA 510(k) clearance on 2020-12-29, under 510(k) number K202456.

Who is the listed applicant for M5 Recorder?

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 M5 Recorder?

The FDA product code for M5 Recorder is DSH.

Other records listing Global Instrumentation, LLC 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.

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Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., 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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