FOCAL SIM— 510(k) K013112

Substantially Equivalent

Computerized Medical Systems, Inc.

FDA 510(k) clearance K013112 for FOCAL SIM, Substantially Equivalent on 2001-12-05. Applicant: Computerized Medical Systems, Inc..

Clearance details

Applicant: Computerized Medical Systems, Inc.
Product code: Code MUJ
Advisory panel: Radiology
Date received: 2001-09-18
Decision date: 2001-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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