OEC One
K-Number: K172700 · 2017-11-09
ApplicantGe Hualun Medical Systems Co. , Ltd.
Decision Date2017-11-09
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OEC One is a medical device manufactured by Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2017-11-09 under approval number K172700. 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 OEC One?
OEC One is a medical device that received FDA 510(k) clearance on 2017-11-09. It is manufactured by Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K172700.
When was OEC One approved by the FDA?
OEC One received FDA 510(k) clearance on 2017-11-09, under approval number K172700.
What company makes OEC One?
OEC One is manufactured by Ge Hualun Medical Systems Co. , Ltd..
What is the FDA product code for OEC One?
The FDA product code for OEC One is OWB.
Other Devices by Ge Hualun Medical Systems Co. , Ltd.
Related Devices (Code: OWB)
K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.
K162148Allura Xper R9Philips Medical Systems Nethrlands BV
K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation
K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd.
K161976Ziehm Solo FDZiehm Imaging GmbH
K161756SyncVision SystemVolcano Corporation
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.