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FDA 510(k)

APEXPRO FH TELEMETRY SYSTEM

K-Number: K033365 · 2003-11-06

ApplicantGe Medical Systems Information Technologies
Decision Date2003-11-06
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APEXPRO FH TELEMETRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 2003-11-06 under 510(k) number K033365. 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 APEXPRO FH TELEMETRY SYSTEM?

APEXPRO FH TELEMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-11-06. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K033365.

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

APEXPRO FH TELEMETRY SYSTEM received FDA 510(k) clearance on 2003-11-06, under 510(k) number K033365.

Who is the listed applicant for APEXPRO FH TELEMETRY SYSTEM?

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

What is the FDA product code for APEXPRO FH TELEMETRY SYSTEM?

The FDA product code for APEXPRO FH TELEMETRY SYSTEM is MHX.

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Other records listing Ge Medical Systems Information Technologies 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.

K120770QT GUARD PLUS ANALYSIS SYSTEMK102426CARESCAPE MODEL V100 VITAL SIGNS MONITORK09236912SL ECG ANALYSIS PROGRAMK093141MARS HOLTER ANALYSIS WORKSTATIONK092027CARESCAPE MONITOR B850K090702MODIFICATION TO DASH 2500 PATIENT MONITOR

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Related Devices (Code: MHX)

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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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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