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FDA 510(k)

ARTIS icono

K-Number: K190768 · 2019-09-12

Decision Date2019-09-12
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARTIS icono is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2019-09-12 under approval number K190768. 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 icono?

ARTIS icono is a medical device that received FDA 510(k) clearance on 2019-09-12. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K190768.

When was ARTIS icono approved by the FDA?

ARTIS icono received FDA 510(k) clearance on 2019-09-12, under approval number K190768.

What company makes ARTIS icono?

ARTIS icono is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for ARTIS icono?

The FDA product code for ARTIS icono is OWB.

Other Devices by Siemens Medical Solutions USA, Inc.

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Related Devices (Code: OWB)

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.