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FDA 510(k)

CARD GUARD, MODEL CG-2000A

K-Number: K910451 · 1991-06-10

ApplicantMedtech Industries, Inc.
Decision Date1991-06-10
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARD GUARD, MODEL CG-2000A is the device name listed in this FDA 510(k) record. The listed applicant is Medtech Industries, Inc.. It received FDA 510(k) clearance on 1991-06-10 under 510(k) number K910451. 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 CARD GUARD, MODEL CG-2000A?

CARD GUARD, MODEL CG-2000A is a medical device that received FDA 510(k) clearance on 1991-06-10. The listed applicant is Medtech Industries, Inc.. The 510(k) number is K910451.

When did CARD GUARD, MODEL CG-2000A receive FDA 510(k) clearance?

CARD GUARD, MODEL CG-2000A received FDA 510(k) clearance on 1991-06-10, under 510(k) number K910451.

Who is the listed applicant for CARD GUARD, MODEL CG-2000A?

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

What is the FDA product code for CARD GUARD, MODEL CG-2000A?

The FDA product code for CARD GUARD, MODEL CG-2000A is DXH. This falls under the Hematology category.

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Other records listing Medtech Industries, Inc. 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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