CARDIOSPECT D90/CARDIO CAM— 510(k) K021823

Name: FDA 510(k) clearance K021823
Creator: U.S. Food and Drug Administration
Published: 2002-06-17

Substantially Equivalent

Nuclear Cardiology Systems, Inc.

FDA 510(k) clearance K021823 for CARDIOSPECT D90/CARDIO CAM, Substantially Equivalent on 2002-06-17. Applicant: Nuclear Cardiology Systems, Inc.. Device class: 2.

Clearance details

Applicant: Nuclear Cardiology Systems, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2002-06-04
Decision date: 2002-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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