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FDA 510(k)

MODIFICATION TO GLOBALCARDIO

K-Number: K033037 · 2003-10-31

ApplicantCardiocomm Solutions, Inc.
Decision Date2003-10-31
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO 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 2003-10-31 under 510(k) number K033037. 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 MODIFICATION TO GLOBALCARDIO?

MODIFICATION TO GLOBALCARDIO is a medical device that received FDA 510(k) clearance on 2003-10-31. The listed applicant is Cardiocomm Solutions, Inc.. The 510(k) number is K033037.

When did MODIFICATION TO GLOBALCARDIO receive FDA 510(k) clearance?

MODIFICATION TO GLOBALCARDIO received FDA 510(k) clearance on 2003-10-31, under 510(k) number K033037.

Who is the listed applicant for MODIFICATION TO 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 MODIFICATION TO GLOBALCARDIO?

The FDA product code for MODIFICATION TO GLOBALCARDIO is DSH.

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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.

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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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