Brainlab Elements Guide XT, Guide 3.0
K-Number: K213930 · 2022-04-19
ApplicantBrainlab AG
Decision Date2022-04-19
Product CodeQQC
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Brainlab Elements Guide XT, Guide 3.0 is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2022-04-19 under approval number K213930. The device is classified under product code QQC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Brainlab Elements Guide XT, Guide 3.0?
Brainlab Elements Guide XT, Guide 3.0 is a medical device that received FDA 510(k) clearance on 2022-04-19. It is manufactured by Brainlab AG. The 510(k) number is K213930.
When was Brainlab Elements Guide XT, Guide 3.0 approved by the FDA?
Brainlab Elements Guide XT, Guide 3.0 received FDA 510(k) clearance on 2022-04-19, under approval number K213930.
What company makes Brainlab Elements Guide XT, Guide 3.0?
Brainlab Elements Guide XT, Guide 3.0 is manufactured by Brainlab AG.
What is the FDA product code for Brainlab Elements Guide XT, Guide 3.0?
The FDA product code for Brainlab Elements Guide XT, Guide 3.0 is QQC.
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Related Devices (Code: QQC)
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.