FDA 510(k)

CEQUAL-QUANTITATIVE ANALYSIS

K-Number: K942363 · 1994-09-16

Decision Date1994-09-16

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CEQUAL-QUANTITATIVE ANALYSIS 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 1994-09-16 under 510(k) number K942363. 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 CEQUAL-QUANTITATIVE ANALYSIS?

CEQUAL-QUANTITATIVE ANALYSIS is a medical device that received FDA 510(k) clearance on 1994-09-16. The listed applicant is Nuccardiac Software, Inc.. The 510(k) number is K942363.

When did CEQUAL-QUANTITATIVE ANALYSIS receive FDA 510(k) clearance?

CEQUAL-QUANTITATIVE ANALYSIS received FDA 510(k) clearance on 1994-09-16, under 510(k) number K942363.

Who is the listed applicant for CEQUAL-QUANTITATIVE ANALYSIS?

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 CEQUAL-QUANTITATIVE ANALYSIS?

The FDA product code for CEQUAL-QUANTITATIVE ANALYSIS is KPS.

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Other records listing Nuccardiac Software, Inc. as applicant

K972509CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER K970288CLINICAL DIAGNOSTIC SOFTWARE K944720COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION K932701CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS K922671CEDARS SINAI QUANTITATIVE THALLIUM 201 ANALYSIS K915644CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS

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Related Devices (Code: KPS)

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.