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FDA 510(k)

TRANSMITTER, TR-1 ECG

K-Number: K782059 · 1978-12-21

ApplicantBurdick Corp.
Decision Date1978-12-21
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSMITTER, TR-1 ECG is the device name listed in this FDA 510(k) record. The listed applicant is Burdick Corp.. It received FDA 510(k) clearance on 1978-12-21 under 510(k) number K782059. 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 TRANSMITTER, TR-1 ECG?

TRANSMITTER, TR-1 ECG is a medical device that received FDA 510(k) clearance on 1978-12-21. The listed applicant is Burdick Corp.. The 510(k) number is K782059.

When did TRANSMITTER, TR-1 ECG receive FDA 510(k) clearance?

TRANSMITTER, TR-1 ECG received FDA 510(k) clearance on 1978-12-21, under 510(k) number K782059.

Who is the listed applicant for TRANSMITTER, TR-1 ECG?

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 TRANSMITTER, TR-1 ECG?

The FDA product code for TRANSMITTER, TR-1 ECG is DXH. This falls under the Hematology category.

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Other records listing Burdick Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K942565ALTAIR-DISC RECORDERK941351BURDICK PRO2 OXIMETERK904032ELITE II ELECTROCARDIOGRAPHK903565E560 ELECTROCARDIOGRAPHK900729NEOSERV 824K885085ERGOMED 840/ERGOMED 840L

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Related Devices (Code: DXH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

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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