CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM— 510(k) K964265

Name: FDA 510(k) clearance K964265
Creator: U.S. Food and Drug Administration
Published: 1996-11-12

Substantially Equivalent

Trionix Research Laboratory, Inc.

FDA 510(k) clearance K964265 for CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM, Substantially Equivalent on 1996-11-12. Applicant: Trionix Research Laboratory, Inc.. Device class: 2.

Clearance details

Applicant: Trionix Research Laboratory, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1996-10-24
Decision date: 1996-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, US

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