FULLCARD ANALYSIS— 510(k) K061587

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K061587 for FULLCARD ANALYSIS, Substantially Equivalent on 2006-06-23. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code KPS
Advisory panel: Radiology
Date received: 2006-06-08
Decision date: 2006-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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