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FDA 510(k)

CARDIOBEEPER CB-12L

K-Number: K965101 · 1997-03-17

ApplicantMeridian Medical Technologies, Inc.
Decision Date1997-03-17
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOBEEPER CB-12L is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Medical Technologies, Inc.. It received FDA 510(k) clearance on 1997-03-17 under 510(k) number K965101. 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 CB-12L?

CARDIOBEEPER CB-12L is a medical device that received FDA 510(k) clearance on 1997-03-17. The listed applicant is Meridian Medical Technologies, Inc.. The 510(k) number is K965101.

When did CARDIOBEEPER CB-12L receive FDA 510(k) clearance?

CARDIOBEEPER CB-12L received FDA 510(k) clearance on 1997-03-17, under 510(k) number K965101.

Who is the listed applicant for CARDIOBEEPER CB-12L?

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

What is the FDA product code for CARDIOBEEPER CB-12L?

The FDA product code for CARDIOBEEPER CB-12L 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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