E-EEGX, N-EEGX
K-Number: K191322 · 2020-01-22
ApplicantGE Healthcare Finland Oy
Decision Date2020-01-22
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
E-EEGX, N-EEGX is a medical device manufactured by GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2020-01-22 under approval number K191322. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the E-EEGX, N-EEGX?
E-EEGX, N-EEGX is a medical device that received FDA 510(k) clearance on 2020-01-22. It is manufactured by GE Healthcare Finland Oy. The 510(k) number is K191322.
When was E-EEGX, N-EEGX approved by the FDA?
E-EEGX, N-EEGX received FDA 510(k) clearance on 2020-01-22, under approval number K191322.
What company makes E-EEGX, N-EEGX?
E-EEGX, N-EEGX is manufactured by GE Healthcare Finland Oy.
What is the FDA product code for E-EEGX, N-EEGX?
The FDA product code for E-EEGX, N-EEGX is OLT.
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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.