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FDA 510(k)

CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410

K-Number: K043454 · 2005-03-24

ApplicantMedicomp, Inc.
Decision Date2005-03-24
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 2005-03-24 under 510(k) number K043454. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410?

CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 is a medical device that received FDA 510(k) clearance on 2005-03-24. The listed applicant is Medicomp, Inc.. The 510(k) number is K043454.

When did CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 receive FDA 510(k) clearance?

CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 received FDA 510(k) clearance on 2005-03-24, under 510(k) number K043454.

Who is the listed applicant for CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410?

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 AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410?

The FDA product code for CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 is MLO.

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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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