Neural Navigator
K-Number: K191422 · 2020-04-06
ApplicantSoterix Medical, Inc.
Decision Date2020-04-06
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Neural Navigator is a medical device manufactured by Soterix Medical, Inc.. It received FDA 510(k) clearance on 2020-04-06 under approval number K191422. 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 Neural Navigator?
Neural Navigator is a medical device that received FDA 510(k) clearance on 2020-04-06. It is manufactured by Soterix Medical, Inc.. The 510(k) number is K191422.
When was Neural Navigator approved by the FDA?
Neural Navigator received FDA 510(k) clearance on 2020-04-06, under approval number K191422.
What company makes Neural Navigator?
Neural Navigator is manufactured by Soterix Medical, Inc..
What is the FDA product code for Neural Navigator?
The FDA product code for Neural Navigator is HAW.
Other Devices by Soterix Medical, Inc.
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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.