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510(k) K163195

PRIMUS by Carl Zeiss Suzhou Co., Ltd. — Product Code OBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2017
Date Received
November 15, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tomography, Optical Coherence
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

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