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

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..

Clearance details

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

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