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FDA 510(k)

CARDIOMAGIC SOFTWARE

K-Number: K925639 · 1993-06-22

ApplicantInstromedix, Inc.
Decision Date1993-06-22
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOMAGIC SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix, Inc.. It received FDA 510(k) clearance on 1993-06-22 under 510(k) number K925639. 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 CARDIOMAGIC SOFTWARE?

CARDIOMAGIC SOFTWARE is a medical device that received FDA 510(k) clearance on 1993-06-22. The listed applicant is Instromedix, Inc.. The 510(k) number is K925639.

When did CARDIOMAGIC SOFTWARE receive FDA 510(k) clearance?

CARDIOMAGIC SOFTWARE received FDA 510(k) clearance on 1993-06-22, under 510(k) number K925639.

Who is the listed applicant for CARDIOMAGIC SOFTWARE?

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

What is the FDA product code for CARDIOMAGIC SOFTWARE?

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

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Other records listing Instromedix, 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

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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