Microscope Navigation
K-Number: K190250 · 2019-09-06
ApplicantBrainlab AG
Decision Date2019-09-06
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Microscope Navigation is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2019-09-06 under approval number K190250. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Microscope Navigation?
Microscope Navigation is a medical device that received FDA 510(k) clearance on 2019-09-06. It is manufactured by Brainlab AG. The 510(k) number is K190250.
When was Microscope Navigation approved by the FDA?
Microscope Navigation received FDA 510(k) clearance on 2019-09-06, under approval number K190250.
What company makes Microscope Navigation?
Microscope Navigation is manufactured by Brainlab AG.
What is the FDA product code for Microscope Navigation?
The FDA product code for Microscope Navigation is HAW.
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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.