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FDA 510(k)

MODIFICATION OF APEXPRO TELEMETRY SYSTEM

K-Number: K021325 · 2002-05-07

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date2002-05-07
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF APEXPRO TELEMETRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Medical Systems Information Techn. It received FDA 510(k) clearance on 2002-05-07 under 510(k) number K021325. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION OF APEXPRO TELEMETRY SYSTEM?

MODIFICATION OF APEXPRO TELEMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 2002-05-07. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K021325.

When did MODIFICATION OF APEXPRO TELEMETRY SYSTEM receive FDA 510(k) clearance?

MODIFICATION OF APEXPRO TELEMETRY SYSTEM received FDA 510(k) clearance on 2002-05-07, under 510(k) number K021325.

Who is the listed applicant for MODIFICATION OF APEXPRO TELEMETRY SYSTEM?

The FDA 510(k) record lists General Electric Medical Systems Information Techn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION OF APEXPRO TELEMETRY SYSTEM?

The FDA product code for MODIFICATION OF APEXPRO TELEMETRY SYSTEM is MHX.

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Other records listing General Electric Medical Systems Information Techn 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.

K023380T-WAVE ALTERMANS (TWA) ALGORITHM OPTIONK021470SEER LIGHT COMPACT DIGITAL HOLTER RECORDERK023100ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTSK021454UNITY NETWORK IDK020290DASH 3000/4000 PATIENT MONITORK021366MAC-LAB/CARDIOLAB EP/COMBOLAB

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Related Devices (Code: MHX)

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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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