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FDA 510(k)

CARDIOBEEPER CB250

K-Number: K983582 · 1998-11-13

ApplicantMerdian Medical Technologies , Ltd.
Decision Date1998-11-13
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOBEEPER CB250 is the device name listed in this FDA 510(k) record. The listed applicant is Merdian Medical Technologies , Ltd.. It received FDA 510(k) clearance on 1998-11-13 under 510(k) number K983582. 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 CARDIOBEEPER CB250?

CARDIOBEEPER CB250 is a medical device that received FDA 510(k) clearance on 1998-11-13. The listed applicant is Merdian Medical Technologies , Ltd.. The 510(k) number is K983582.

When did CARDIOBEEPER CB250 receive FDA 510(k) clearance?

CARDIOBEEPER CB250 received FDA 510(k) clearance on 1998-11-13, under 510(k) number K983582.

Who is the listed applicant for CARDIOBEEPER CB250?

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

What is the FDA product code for CARDIOBEEPER CB250?

The FDA product code for CARDIOBEEPER CB250 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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