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FDA 510(k)

CARDIO ARRHYTHMIA TRANSMITTER C.A.T

K-Number: K830903 · 1983-07-26

ApplicantCardio Technology , Ltd.
Decision Date1983-07-26
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO ARRHYTHMIA TRANSMITTER C.A.T is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Technology , Ltd.. It received FDA 510(k) clearance on 1983-07-26 under 510(k) number K830903. 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 CARDIO ARRHYTHMIA TRANSMITTER C.A.T?

CARDIO ARRHYTHMIA TRANSMITTER C.A.T is a medical device that received FDA 510(k) clearance on 1983-07-26. The listed applicant is Cardio Technology , Ltd.. The 510(k) number is K830903.

When did CARDIO ARRHYTHMIA TRANSMITTER C.A.T receive FDA 510(k) clearance?

CARDIO ARRHYTHMIA TRANSMITTER C.A.T received FDA 510(k) clearance on 1983-07-26, under 510(k) number K830903.

Who is the listed applicant for CARDIO ARRHYTHMIA TRANSMITTER C.A.T?

The FDA 510(k) record lists Cardio Technology , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIO ARRHYTHMIA TRANSMITTER C.A.T?

The FDA product code for CARDIO ARRHYTHMIA TRANSMITTER C.A.T is DXH. This falls under the Hematology category.

Related Clinical Trials

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Other records listing Cardio Technology , Ltd. 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.

K821711CARDIO TEHCHANALYZER

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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