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FDA 510(k)

TELEMETRY SYSTEM

K-Number: K823906 · 1983-03-09

ApplicantTranskinetic Systems, Inc.
Decision Date1983-03-09
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TELEMETRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Transkinetic Systems, Inc.. It received FDA 510(k) clearance on 1983-03-09 under 510(k) number K823906. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELEMETRY SYSTEM?

TELEMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is Transkinetic Systems, Inc.. The 510(k) number is K823906.

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

TELEMETRY SYSTEM received FDA 510(k) clearance on 1983-03-09, under 510(k) number K823906.

Who is the listed applicant for TELEMETRY SYSTEM?

The FDA 510(k) record lists Transkinetic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TELEMETRY SYSTEM?

The FDA product code for TELEMETRY SYSTEM is DRG.

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Related Devices (Code: DRG)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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