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FDA 510(k)

TELETRACE TELEPHONE EKG SYSTEM

K-Number: K811512 · 1981-06-30

ApplicantMedtronic Vascular
Decision Date1981-06-30
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TELETRACE TELEPHONE EKG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1981-06-30 under 510(k) number K811512. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELETRACE TELEPHONE EKG SYSTEM?

TELETRACE TELEPHONE EKG SYSTEM is a medical device that received FDA 510(k) clearance on 1981-06-30. The listed applicant is Medtronic Vascular. The 510(k) number is K811512.

When did TELETRACE TELEPHONE EKG SYSTEM receive FDA 510(k) clearance?

TELETRACE TELEPHONE EKG SYSTEM received FDA 510(k) clearance on 1981-06-30, under 510(k) number K811512.

Who is the listed applicant for TELETRACE TELEPHONE EKG SYSTEM?

The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TELETRACE TELEPHONE EKG SYSTEM?

The FDA product code for TELETRACE TELEPHONE EKG SYSTEM is DXH. This falls under the Hematology category.

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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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