CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS— 510(k) K915644

Name: FDA 510(k) clearance K915644
Creator: U.S. Food and Drug Administration
Published: 1992-02-27

Substantially Equivalent

Nuccardiac Software, Inc.

FDA 510(k) clearance K915644 for CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS, Substantially Equivalent on 1992-02-27. Applicant: Nuccardiac Software, Inc.. Device class: 2.

Clearance details

Applicant: Nuccardiac Software, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1991-12-17
Decision date: 1992-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torba Linda, CA, US

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