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FDA 510(k)

CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS

K-Number: K950003 · 1995-10-31

ApplicantInstromedix, Inc.
Decision Date1995-10-31
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix, Inc.. It received FDA 510(k) clearance on 1995-10-31 under 510(k) number K950003. 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(R) SOFTWARE ENHANCEMENTS?

CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS is a medical device that received FDA 510(k) clearance on 1995-10-31. The listed applicant is Instromedix, Inc.. The 510(k) number is K950003.

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

CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS received FDA 510(k) clearance on 1995-10-31, under 510(k) number K950003.

Who is the listed applicant for CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS?

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(R) SOFTWARE ENHANCEMENTS?

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

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Other records listing Instromedix, Inc. as applicant

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Related Devices (Code: DXH)

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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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