FDA 510(k)

MODEL 9444 TELETRACE II ECG MONITORING SYSTEM

K-Number: K903960 · 1990-10-09

Decision Date1990-10-09

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODEL 9444 TELETRACE II ECG MONITORING 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 1990-10-09 under 510(k) number K903960. 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 MODEL 9444 TELETRACE II ECG MONITORING SYSTEM?

MODEL 9444 TELETRACE II ECG MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1990-10-09. The listed applicant is Medtronic Vascular. The 510(k) number is K903960.

When did MODEL 9444 TELETRACE II ECG MONITORING SYSTEM receive FDA 510(k) clearance?

MODEL 9444 TELETRACE II ECG MONITORING SYSTEM received FDA 510(k) clearance on 1990-10-09, under 510(k) number K903960.

Who is the listed applicant for MODEL 9444 TELETRACE II ECG MONITORING 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 MODEL 9444 TELETRACE II ECG MONITORING SYSTEM?

The FDA product code for MODEL 9444 TELETRACE II ECG MONITORING 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.