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FDA 510(k)

MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370

K-Number: K050951 · 2005-07-19

ApplicantCibernet Systems Corp.
Decision Date2005-07-19
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 is the device name listed in this FDA 510(k) record. The listed applicant is Cibernet Systems Corp.. It received FDA 510(k) clearance on 2005-07-19 under 510(k) number K050951. 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 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370?

MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 is a medical device that received FDA 510(k) clearance on 2005-07-19. The listed applicant is Cibernet Systems Corp.. The 510(k) number is K050951.

When did MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 receive FDA 510(k) clearance?

MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 received FDA 510(k) clearance on 2005-07-19, under 510(k) number K050951.

Who is the listed applicant for MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370?

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

What is the FDA product code for MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370?

The FDA product code for MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 is DXH. This falls under the Hematology category.

Related Clinical Trials

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Related Devices (Code: DXH)

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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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