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FDA 510(k)

CARDIOMPO TEST

K-Number: K050029 · 2005-05-10

ApplicantPrognostix, Inc.
Decision Date2005-05-10
Product CodeNTV
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CARDIOMPO TEST is the device name listed in this FDA 510(k) record. The listed applicant is Prognostix, Inc.. It received FDA 510(k) clearance on 2005-05-10 under 510(k) number K050029. The device is classified under product code NTV. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOMPO TEST?

CARDIOMPO TEST is a medical device that received FDA 510(k) clearance on 2005-05-10. The listed applicant is Prognostix, Inc.. The 510(k) number is K050029.

When did CARDIOMPO TEST receive FDA 510(k) clearance?

CARDIOMPO TEST received FDA 510(k) clearance on 2005-05-10, under 510(k) number K050029.

Who is the listed applicant for CARDIOMPO TEST?

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

What is the FDA product code for CARDIOMPO TEST?

The FDA product code for CARDIOMPO TEST is NTV.

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Related Devices (Code: NTV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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