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FDA 510(k)

Artis zee/zeego & Artis Q/Q.zen

K-Number: K181407 · 2018-08-15

ApplicantSiemens Medical Solution USA, Inc.
Decision Date2018-08-15
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Artis zee/zeego & Artis Q/Q.zen is a medical device manufactured by Siemens Medical Solution USA, Inc.. It received FDA 510(k) clearance on 2018-08-15 under approval number K181407. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Artis zee/zeego & Artis Q/Q.zen?

Artis zee/zeego & Artis Q/Q.zen is a medical device that received FDA 510(k) clearance on 2018-08-15. It is manufactured by Siemens Medical Solution USA, Inc.. The 510(k) number is K181407.

When was Artis zee/zeego & Artis Q/Q.zen approved by the FDA?

Artis zee/zeego & Artis Q/Q.zen received FDA 510(k) clearance on 2018-08-15, under approval number K181407.

What company makes Artis zee/zeego & Artis Q/Q.zen?

Artis zee/zeego & Artis Q/Q.zen is manufactured by Siemens Medical Solution USA, Inc..

What is the FDA product code for Artis zee/zeego & Artis Q/Q.zen?

The FDA product code for Artis zee/zeego & Artis Q/Q.zen is OWB.

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Official Source

View on FDA Database →

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

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