Optima XR646 HD
K-Number: K173612 · 2017-12-11
ApplicantGe Hualun Medical Systems Co. , Ltd.
Decision Date2017-12-11
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Optima XR646 HD is a medical device manufactured by Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2017-12-11 under approval number K173612. 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 Optima XR646 HD?
Optima XR646 HD is a medical device that received FDA 510(k) clearance on 2017-12-11. It is manufactured by Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K173612.
When was Optima XR646 HD approved by the FDA?
Optima XR646 HD received FDA 510(k) clearance on 2017-12-11, under approval number K173612.
What company makes Optima XR646 HD?
Optima XR646 HD is manufactured by Ge Hualun Medical Systems Co. , Ltd..
What is the FDA product code for Optima XR646 HD?
The FDA product code for Optima XR646 HD 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.