Elements Viewer
K-Number: K191014 · 2020-01-23
ApplicantBrainlab AG
Decision Date2020-01-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Elements Viewer is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2020-01-23 under approval number K191014. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elements Viewer?
Elements Viewer is a medical device that received FDA 510(k) clearance on 2020-01-23. It is manufactured by Brainlab AG. The 510(k) number is K191014.
When was Elements Viewer approved by the FDA?
Elements Viewer received FDA 510(k) clearance on 2020-01-23, under approval number K191014.
What company makes Elements Viewer?
Elements Viewer is manufactured by Brainlab AG.
What is the FDA product code for Elements Viewer?
The FDA product code for Elements Viewer is LLZ.
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Related Devices (Code: LLZ)
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.