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FDA 510(k)

CARDIOMAGIC 2000 SOFTWARE

K-Number: K964036 · 1997-07-18

ApplicantInstromedix, Inc.
Decision Date1997-07-18
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOMAGIC 2000 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 1997-07-18 under 510(k) number K964036. 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 2000 SOFTWARE?

CARDIOMAGIC 2000 SOFTWARE is a medical device that received FDA 510(k) clearance on 1997-07-18. The listed applicant is Instromedix, Inc.. The 510(k) number is K964036.

When did CARDIOMAGIC 2000 SOFTWARE receive FDA 510(k) clearance?

CARDIOMAGIC 2000 SOFTWARE received FDA 510(k) clearance on 1997-07-18, under 510(k) number K964036.

Who is the listed applicant for CARDIOMAGIC 2000 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 2000 SOFTWARE?

The FDA product code for CARDIOMAGIC 2000 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.

K964408POSEIDON CARDIAC MONITORING SYSTEM (PCMS)K955060ACCELERATED TRANSMISSION PROTOCOLK951096LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVERK945476HEARTHWATCH III(TM)K950003CARDIOMAGIC(R) SOFTWARE ENHANCEMENTSK944362HEARTCARD CARDIAC EVENT MONITOR

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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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