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FDA 510(k)

CARDIOPAL MODEL NUMBER PM20

K-Number: K981119 · 1998-10-14

ApplicantMedicomp, Inc.
Decision Date1998-10-14
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPAL MODEL NUMBER PM20 is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 1998-10-14 under 510(k) number K981119. 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 CARDIOPAL MODEL NUMBER PM20?

CARDIOPAL MODEL NUMBER PM20 is a medical device that received FDA 510(k) clearance on 1998-10-14. The listed applicant is Medicomp, Inc.. The 510(k) number is K981119.

When did CARDIOPAL MODEL NUMBER PM20 receive FDA 510(k) clearance?

CARDIOPAL MODEL NUMBER PM20 received FDA 510(k) clearance on 1998-10-14, under 510(k) number K981119.

Who is the listed applicant for CARDIOPAL MODEL NUMBER PM20?

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

What is the FDA product code for CARDIOPAL MODEL NUMBER PM20?

The FDA product code for CARDIOPAL MODEL NUMBER PM20 is DXH. This falls under the Hematology category.

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Other records listing Medicomp, Inc. as applicant

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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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