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FDA 510(k)

PMP4 MEDICAL WEB CENTER

K-Number: K050940 · 2005-07-01

ApplicantCard Guard Scientific Survival , Ltd.
Decision Date2005-07-01
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PMP4 MEDICAL WEB CENTER is the device name listed in this FDA 510(k) record. The listed applicant is Card Guard Scientific Survival , Ltd.. It received FDA 510(k) clearance on 2005-07-01 under 510(k) number K050940. 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 PMP4 MEDICAL WEB CENTER?

PMP4 MEDICAL WEB CENTER is a medical device that received FDA 510(k) clearance on 2005-07-01. The listed applicant is Card Guard Scientific Survival , Ltd.. The 510(k) number is K050940.

When did PMP4 MEDICAL WEB CENTER receive FDA 510(k) clearance?

PMP4 MEDICAL WEB CENTER received FDA 510(k) clearance on 2005-07-01, under 510(k) number K050940.

Who is the listed applicant for PMP4 MEDICAL WEB CENTER?

The FDA 510(k) record lists Card Guard Scientific Survival , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PMP4 MEDICAL WEB CENTER?

The FDA product code for PMP4 MEDICAL WEB CENTER is DXH. This falls under the Hematology category.

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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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