MOBILE COMPACT DIGITAL CARDIAC CAMERA— 510(k) K040057

Name: FDA 510(k) clearance K040057
Creator: U.S. Food and Drug Administration
Published: 2004-02-02

Substantially Equivalent

Is2 Research, Inc.

FDA 510(k) clearance K040057 for MOBILE COMPACT DIGITAL CARDIAC CAMERA, Substantially Equivalent on 2004-02-02. Applicant: Is2 Research, Inc.. Device class: 2.

Clearance details

Applicant: Is2 Research, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2004-01-13
Decision date: 2004-02-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Ottawa, Ontario, CA

Download summary PDF View on FDA.gov ↗

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