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FDA 510(k)

CARDIOPHONE

K-Number: K894856 · 1990-01-18

ApplicantEuro-American Marketing Group, Inc.
Decision Date1990-01-18
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPHONE is the device name listed in this FDA 510(k) record. The listed applicant is Euro-American Marketing Group, Inc.. It received FDA 510(k) clearance on 1990-01-18 under 510(k) number K894856. 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 CARDIOPHONE?

CARDIOPHONE is a medical device that received FDA 510(k) clearance on 1990-01-18. The listed applicant is Euro-American Marketing Group, Inc.. The 510(k) number is K894856.

When did CARDIOPHONE receive FDA 510(k) clearance?

CARDIOPHONE received FDA 510(k) clearance on 1990-01-18, under 510(k) number K894856.

Who is the listed applicant for CARDIOPHONE?

The FDA 510(k) record lists Euro-American Marketing Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOPHONE?

The FDA product code for CARDIOPHONE is DXH. This falls under the Hematology category.

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Other records listing Euro-American Marketing Group, Inc. 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.

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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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