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FDA 510(k)

GLOBAL ECG MANAGEMENT SYSTEM (GEMS)

K-Number: K020366 · 2002-04-30

ApplicantCardiocomm Solutions, Inc.
Decision Date2002-04-30
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GLOBAL ECG MANAGEMENT SYSTEM (GEMS) 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 2002-04-30 under 510(k) number K020366. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOBAL ECG MANAGEMENT SYSTEM (GEMS)?

GLOBAL ECG MANAGEMENT SYSTEM (GEMS) is a medical device that received FDA 510(k) clearance on 2002-04-30. The listed applicant is Cardiocomm Solutions, Inc.. The 510(k) number is K020366.

When did GLOBAL ECG MANAGEMENT SYSTEM (GEMS) receive FDA 510(k) clearance?

GLOBAL ECG MANAGEMENT SYSTEM (GEMS) received FDA 510(k) clearance on 2002-04-30, under 510(k) number K020366.

Who is the listed applicant for GLOBAL ECG MANAGEMENT SYSTEM (GEMS)?

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 GLOBAL ECG MANAGEMENT SYSTEM (GEMS)?

The FDA product code for GLOBAL ECG MANAGEMENT SYSTEM (GEMS) is DPS.

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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: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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