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FDA 510(k)

CARDIOSTATION

K-Number: K980624 · 1998-05-11

ApplicantUniversal Medical, Inc.
Decision Date1998-05-11
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Universal Medical, Inc.. It received FDA 510(k) clearance on 1998-05-11 under 510(k) number K980624. 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 CARDIOSTATION?

CARDIOSTATION is a medical device that received FDA 510(k) clearance on 1998-05-11. The listed applicant is Universal Medical, Inc.. The 510(k) number is K980624.

When did CARDIOSTATION receive FDA 510(k) clearance?

CARDIOSTATION received FDA 510(k) clearance on 1998-05-11, under 510(k) number K980624.

Who is the listed applicant for CARDIOSTATION?

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

What is the FDA product code for CARDIOSTATION?

The FDA product code for CARDIOSTATION is DXH. This falls under the Hematology category.

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Other records listing Universal Medical, Inc. as applicant

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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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