CARDIOCAM MODEL 9CSY0799— 510(k) K011611

Substantially Equivalent

Danish Diagnostic Development A/S

FDA 510(k) clearance K011611 for CARDIOCAM MODEL 9CSY0799, Substantially Equivalent on 2001-06-08. Applicant: Danish Diagnostic Development A/S.

Clearance details

Applicant: Danish Diagnostic Development A/S
Product code: Code KPS
Advisory panel: Radiology
Date received: 2001-05-25
Decision date: 2001-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horsholm, DK

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