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FDA 510(k)

ARTIS pheno (VE21) System

K-Number: K220409 · 2022-06-29

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2022-06-29
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARTIS pheno (VE21) System is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2022-06-29 under approval number K220409. 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 pheno (VE21) System?

ARTIS pheno (VE21) System is a medical device that received FDA 510(k) clearance on 2022-06-29. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K220409.

When was ARTIS pheno (VE21) System approved by the FDA?

ARTIS pheno (VE21) System received FDA 510(k) clearance on 2022-06-29, under approval number K220409.

What company makes ARTIS pheno (VE21) System?

ARTIS pheno (VE21) System is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for ARTIS pheno (VE21) System?

The FDA product code for ARTIS pheno (VE21) System 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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