PRIMUS— 510(k) K163195

Substantially Equivalent

Carl Zeiss Suzhou Co., Ltd.

FDA 510(k) clearance K163195 for PRIMUS, Substantially Equivalent on 2017-06-21. Applicant: Carl Zeiss Suzhou Co., Ltd.. Device class: 2.

Clearance details

Applicant: Carl Zeiss Suzhou Co., Ltd.
Product code: Code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2016-11-15
Decision date: 2017-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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