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FDA 510(k)

CARDIOBEEPER CB12/12, MODEL CB12/12

K-Number: K002310 · 2000-10-25

ApplicantMeridian Medical Technologies , Ltd.
Decision Date2000-10-25
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOBEEPER CB12/12, MODEL CB12/12 is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Medical Technologies , Ltd.. It received FDA 510(k) clearance on 2000-10-25 under 510(k) number K002310. 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 CB12/12, MODEL CB12/12?

CARDIOBEEPER CB12/12, MODEL CB12/12 is a medical device that received FDA 510(k) clearance on 2000-10-25. The listed applicant is Meridian Medical Technologies , Ltd.. The 510(k) number is K002310.

When did CARDIOBEEPER CB12/12, MODEL CB12/12 receive FDA 510(k) clearance?

CARDIOBEEPER CB12/12, MODEL CB12/12 received FDA 510(k) clearance on 2000-10-25, under 510(k) number K002310.

Who is the listed applicant for CARDIOBEEPER CB12/12, MODEL CB12/12?

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

What is the FDA product code for CARDIOBEEPER CB12/12, MODEL CB12/12?

The FDA product code for CARDIOBEEPER CB12/12, MODEL CB12/12 is DXH. This falls under the Hematology category.

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Other records listing Meridian Medical Technologies , Ltd. as applicant

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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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