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FDA 510(k)

BRIDGE III RECEIVER

K-Number: K010794 · 2001-05-10

ApplicantMeridian Medical Technologies , Ltd.
Decision Date2001-05-10
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BRIDGE III RECEIVER 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 2001-05-10 under 510(k) number K010794. 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 BRIDGE III RECEIVER?

BRIDGE III RECEIVER is a medical device that received FDA 510(k) clearance on 2001-05-10. The listed applicant is Meridian Medical Technologies , Ltd.. The 510(k) number is K010794.

When did BRIDGE III RECEIVER receive FDA 510(k) clearance?

BRIDGE III RECEIVER received FDA 510(k) clearance on 2001-05-10, under 510(k) number K010794.

Who is the listed applicant for BRIDGE III RECEIVER?

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 BRIDGE III RECEIVER?

The FDA product code for BRIDGE III RECEIVER 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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