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FDA 510(k)

APEXPRO TELEMETRY SYSTEM

K-Number: K000779 · 2000-05-18

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date2000-05-18
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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 2000-05-18 under 510(k) number K000779. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APEXPRO TELEMETRY SYSTEM?

APEXPRO TELEMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 2000-05-18. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K000779.

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

APEXPRO TELEMETRY SYSTEM received FDA 510(k) clearance on 2000-05-18, under 510(k) number K000779.

Who is the listed applicant for 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 APEXPRO TELEMETRY SYSTEM?

The FDA product code for APEXPRO TELEMETRY SYSTEM is DSI.

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Other records listing General Electric Medical Systems Information Techn as applicant

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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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