ENT EM
K-Number: K223734 · 2023-04-27
ApplicantBrainlab AG
Decision Date2023-04-27
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ENT EM is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2023-04-27 under approval number K223734. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ENT EM?
ENT EM is a medical device that received FDA 510(k) clearance on 2023-04-27. It is manufactured by Brainlab AG. The 510(k) number is K223734.
When was ENT EM approved by the FDA?
ENT EM received FDA 510(k) clearance on 2023-04-27, under approval number K223734.
What company makes ENT EM?
ENT EM is manufactured by Brainlab AG.
What is the FDA product code for ENT EM?
The FDA product code for ENT EM is PGW.
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K190250Microscope Navigation
K183605Spine & Trauma Navigation
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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.