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510(k) K180162

VivaScope System by Caliber Imaging & Diagnostics, Inc. — Product Code PSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2018
Date Received
January 19, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Imaging
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Emission and collection of light to create an image for medical purposes

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