FDA 510(k)

CLINICAL DIAGNOSTIC SOFTWARE

K-Number: K970288 · 1997-04-24

Decision Date1997-04-24

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CLINICAL DIAGNOSTIC SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Nuccardiac Software, Inc.. It received FDA 510(k) clearance on 1997-04-24 under 510(k) number K970288. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINICAL DIAGNOSTIC SOFTWARE?

CLINICAL DIAGNOSTIC SOFTWARE is a medical device that received FDA 510(k) clearance on 1997-04-24. The listed applicant is Nuccardiac Software, Inc.. The 510(k) number is K970288.

When did CLINICAL DIAGNOSTIC SOFTWARE receive FDA 510(k) clearance?

CLINICAL DIAGNOSTIC SOFTWARE received FDA 510(k) clearance on 1997-04-24, under 510(k) number K970288.

Who is the listed applicant for CLINICAL DIAGNOSTIC SOFTWARE?

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

What is the FDA product code for CLINICAL DIAGNOSTIC SOFTWARE?

The FDA product code for CLINICAL DIAGNOSTIC SOFTWARE is KPS.

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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.