FDA 510(k)

PRIMUS

K-Number: K163195 · 2017-06-21

Decision Date2017-06-21

Product CodeOBO

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

PRIMUS is a medical device manufactured by Carl Zeiss Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2017-06-21 under approval number K163195. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMUS?

PRIMUS is a medical device that received FDA 510(k) clearance on 2017-06-21. It is manufactured by Carl Zeiss Suzhou Co., Ltd.. The 510(k) number is K163195.

When was PRIMUS approved by the FDA?

PRIMUS received FDA 510(k) clearance on 2017-06-21, under approval number K163195.

What company makes PRIMUS?

PRIMUS is manufactured by Carl Zeiss Suzhou Co., Ltd..

What is the FDA product code for PRIMUS?

The FDA product code for PRIMUS is OBO.

Other Devices by Carl Zeiss Suzhou Co., Ltd.

K171007Fluorescence Mode

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.