YSIO X.pree
K-Number: K201670 · 2020-10-21
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2020-10-21
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
YSIO X.pree is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-10-21 under approval number K201670. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the YSIO X.pree?
YSIO X.pree is a medical device that received FDA 510(k) clearance on 2020-10-21. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K201670.
When was YSIO X.pree approved by the FDA?
YSIO X.pree received FDA 510(k) clearance on 2020-10-21, under approval number K201670.
What company makes YSIO X.pree?
YSIO X.pree is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for YSIO X.pree?
The FDA product code for YSIO X.pree is KPR.
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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.