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FDA 510(k)

MODIFICATION TO: APEXPRO TELEMETRY SYSTEM

K-Number: K032369 · 2003-08-15

ApplicantGe Medical Systems Information Technologies
Decision Date2003-08-15
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: APEXPRO 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 2003-08-15 under 510(k) number K032369. 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 TO: APEXPRO TELEMETRY SYSTEM?

MODIFICATION TO: APEXPRO TELEMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-08-15. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K032369.

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

MODIFICATION TO: APEXPRO TELEMETRY SYSTEM received FDA 510(k) clearance on 2003-08-15, under 510(k) number K032369.

Who is the listed applicant for MODIFICATION TO: APEXPRO 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 MODIFICATION TO: APEXPRO TELEMETRY SYSTEM?

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

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Other records listing Ge Medical Systems Information Technologies as applicant

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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.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

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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