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FDA 510(k)

TR-3 TRANSMITTER

K-Number: K760857 · 1977-01-28

ApplicantBurdick Corp.
Decision Date1977-01-28
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TR-3 TRANSMITTER is the device name listed in this FDA 510(k) record. The listed applicant is Burdick Corp.. It received FDA 510(k) clearance on 1977-01-28 under 510(k) number K760857. 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 TR-3 TRANSMITTER?

TR-3 TRANSMITTER is a medical device that received FDA 510(k) clearance on 1977-01-28. The listed applicant is Burdick Corp.. The 510(k) number is K760857.

When did TR-3 TRANSMITTER receive FDA 510(k) clearance?

TR-3 TRANSMITTER received FDA 510(k) clearance on 1977-01-28, under 510(k) number K760857.

Who is the listed applicant for TR-3 TRANSMITTER?

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

What is the FDA product code for TR-3 TRANSMITTER?

The FDA product code for TR-3 TRANSMITTER is DXH. This falls under the Hematology category.

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Other records listing Burdick Corp. as applicant

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K942565ALTAIR-DISC RECORDERK941351BURDICK PRO2 OXIMETERK903565E560 ELECTROCARDIOGRAPHK904032ELITE II ELECTROCARDIOGRAPHK900729NEOSERV 824K885085ERGOMED 840/ERGOMED 840L

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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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