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FDA 510(k)

MEDSTAR SYSTEM, MODELS 533-300

K-Number: K020534 · 2003-02-11

ApplicantCybernet Medical
Decision Date2003-02-11
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDSTAR SYSTEM, MODELS 533-300 is the device name listed in this FDA 510(k) record. The listed applicant is Cybernet Medical. It received FDA 510(k) clearance on 2003-02-11 under 510(k) number K020534. 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 MEDSTAR SYSTEM, MODELS 533-300?

MEDSTAR SYSTEM, MODELS 533-300 is a medical device that received FDA 510(k) clearance on 2003-02-11. The listed applicant is Cybernet Medical. The 510(k) number is K020534.

When did MEDSTAR SYSTEM, MODELS 533-300 receive FDA 510(k) clearance?

MEDSTAR SYSTEM, MODELS 533-300 received FDA 510(k) clearance on 2003-02-11, under 510(k) number K020534.

Who is the listed applicant for MEDSTAR SYSTEM, MODELS 533-300?

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

What is the FDA product code for MEDSTAR SYSTEM, MODELS 533-300?

The FDA product code for MEDSTAR SYSTEM, MODELS 533-300 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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