OEC Elite
K-Number: K192819 · 2019-11-08
ApplicantGe Oec Medical Systems, Inc.
Decision Date2019-11-08
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OEC Elite is a medical device manufactured by Ge Oec Medical Systems, Inc.. It received FDA 510(k) clearance on 2019-11-08 under approval number K192819. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OEC Elite?
OEC Elite is a medical device that received FDA 510(k) clearance on 2019-11-08. It is manufactured by Ge Oec Medical Systems, Inc.. The 510(k) number is K192819.
When was OEC Elite approved by the FDA?
OEC Elite received FDA 510(k) clearance on 2019-11-08, under approval number K192819.
What company makes OEC Elite?
OEC Elite is manufactured by Ge Oec Medical Systems, Inc..
What is the FDA product code for OEC Elite?
The FDA product code for OEC Elite is OXO.
Other Devices by Ge Oec Medical Systems, Inc.
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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.