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FDA 510(k)

GLOBALCARDIO

K-Number: K013354 · 2002-01-31

ApplicantCardiocomm Solutions, Inc.
Decision Date2002-01-31
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GLOBALCARDIO is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocomm Solutions, Inc.. It received FDA 510(k) clearance on 2002-01-31 under 510(k) number K013354. 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 GLOBALCARDIO?

GLOBALCARDIO is a medical device that received FDA 510(k) clearance on 2002-01-31. The listed applicant is Cardiocomm Solutions, Inc.. The 510(k) number is K013354.

When did GLOBALCARDIO receive FDA 510(k) clearance?

GLOBALCARDIO received FDA 510(k) clearance on 2002-01-31, under 510(k) number K013354.

Who is the listed applicant for GLOBALCARDIO?

The FDA 510(k) record lists Cardiocomm Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOBALCARDIO?

The FDA product code for GLOBALCARDIO is DSH.

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.

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Other records listing Cardiocomm Solutions, Inc. 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.

K181310HeartCheck Cardi Beat ECG Monitor with GEMS MobileK121009HEARTCHECK ECG PEN WITH GEMS HOMEK111159HEARTCHECK PEN HANDHELD ECG WITH GEMS HOMEK111320GLOBALCARDIOK033037MODIFICATION TO GLOBALCARDIOK022297GLOBAL ECG MANAGEMENT SYSTEM (GEMS)

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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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