FDA 510(k)

MEDTRONIC MODEL 9410 TELETRACE RECEIVER

K-Number: K791778 · 1979-10-02

Decision Date1979-10-02

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC MODEL 9410 TELETRACE RECEIVER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1979-10-02 under 510(k) number K791778. 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 MEDTRONIC MODEL 9410 TELETRACE RECEIVER?

MEDTRONIC MODEL 9410 TELETRACE RECEIVER is a medical device that received FDA 510(k) clearance on 1979-10-02. The listed applicant is Medtronic Vascular. The 510(k) number is K791778.

When did MEDTRONIC MODEL 9410 TELETRACE RECEIVER receive FDA 510(k) clearance?

MEDTRONIC MODEL 9410 TELETRACE RECEIVER received FDA 510(k) clearance on 1979-10-02, under 510(k) number K791778.

Who is the listed applicant for MEDTRONIC MODEL 9410 TELETRACE RECEIVER?

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 MEDTRONIC MODEL 9410 TELETRACE RECEIVER?

The FDA product code for MEDTRONIC MODEL 9410 TELETRACE RECEIVER 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.