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FDA 510(k)

MODEL TRC-40 TELEMETRY RECIEVER MODULE

K-Number: K851623 · 1986-01-22

ApplicantEaton Medical Group
Decision Date1986-01-22
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL TRC-40 TELEMETRY RECIEVER MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Eaton Medical Group. It received FDA 510(k) clearance on 1986-01-22 under 510(k) number K851623. 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 TRC-40 TELEMETRY RECIEVER MODULE?

MODEL TRC-40 TELEMETRY RECIEVER MODULE is a medical device that received FDA 510(k) clearance on 1986-01-22. The listed applicant is Eaton Medical Group. The 510(k) number is K851623.

When did MODEL TRC-40 TELEMETRY RECIEVER MODULE receive FDA 510(k) clearance?

MODEL TRC-40 TELEMETRY RECIEVER MODULE received FDA 510(k) clearance on 1986-01-22, under 510(k) number K851623.

Who is the listed applicant for MODEL TRC-40 TELEMETRY RECIEVER MODULE?

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

What is the FDA product code for MODEL TRC-40 TELEMETRY RECIEVER MODULE?

The FDA product code for MODEL TRC-40 TELEMETRY RECIEVER MODULE is DXH. This falls under the Hematology category.

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Other records listing Eaton Medical Group 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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