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FDA 510(k)

HEARTCARD, MODEL 5258

K-Number: K010945 · 2001-06-12

ApplicantInstromedix
Decision Date2001-06-12
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTCARD, MODEL 5258 is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix. It received FDA 510(k) clearance on 2001-06-12 under 510(k) number K010945. 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 HEARTCARD, MODEL 5258?

HEARTCARD, MODEL 5258 is a medical device that received FDA 510(k) clearance on 2001-06-12. The listed applicant is Instromedix. The 510(k) number is K010945.

When did HEARTCARD, MODEL 5258 receive FDA 510(k) clearance?

HEARTCARD, MODEL 5258 received FDA 510(k) clearance on 2001-06-12, under 510(k) number K010945.

Who is the listed applicant for HEARTCARD, MODEL 5258?

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

What is the FDA product code for HEARTCARD, MODEL 5258?

The FDA product code for HEARTCARD, MODEL 5258 is DXH. This falls under the Hematology category.

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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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