COMPACT DIGITAL CARDIAC CAMERA (CDCC)— 510(k) K033199

Name: FDA 510(k) clearance K033199
Creator: U.S. Food and Drug Administration
Published: 2003-11-12

Substantially Equivalent

Is2 Medical Systems, Inc.

FDA 510(k) clearance K033199 for COMPACT DIGITAL CARDIAC CAMERA (CDCC), Substantially Equivalent on 2003-11-12. Applicant: Is2 Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Is2 Medical Systems, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2003-10-02
Decision date: 2003-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, Ontario, CA

Download summary PDF View on FDA.gov ↗

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