Neuromonitoring Kit
K-Number: K161893 · 2016-10-18
ApplicantSI-BONE, Inc.
Decision Date2016-10-18
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Neuromonitoring Kit is a medical device manufactured by SI-BONE, Inc.. It received FDA 510(k) clearance on 2016-10-18 under approval number K161893. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Neuromonitoring Kit?
Neuromonitoring Kit is a medical device that received FDA 510(k) clearance on 2016-10-18. It is manufactured by SI-BONE, Inc.. The 510(k) number is K161893.
When was Neuromonitoring Kit approved by the FDA?
Neuromonitoring Kit received FDA 510(k) clearance on 2016-10-18, under approval number K161893.
What company makes Neuromonitoring Kit?
Neuromonitoring Kit is manufactured by SI-BONE, Inc..
What is the FDA product code for Neuromonitoring Kit?
The FDA product code for Neuromonitoring Kit is PDQ.
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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.