ENFANTTM— 510(k) K043491

Substantially Equivalent

Diopsys, Inc.

FDA 510(k) clearance K043491 for ENFANTTM, Substantially Equivalent on 2005-03-16. Applicant: Diopsys, Inc..

Clearance details

Applicant: Diopsys, Inc.
Product code: Code GWE
Advisory panel: Neurology
Date received: 2004-12-17
Decision date: 2005-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pine Brook, NJ, US

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