510(k) K152160

Navik 3D by Apn Health, LLC — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2016
Date Received
August 3, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type