Digital ClarusScope System; Digital NeuroPEN System
K-Number: K240535 · 2024-04-25
ApplicantClarus Medical, LLC
Decision Date2024-04-25
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Digital ClarusScope System; Digital NeuroPEN System is a medical device manufactured by Clarus Medical, LLC. It received FDA 510(k) clearance on 2024-04-25 under approval number K240535. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Digital ClarusScope System; Digital NeuroPEN System?
Digital ClarusScope System; Digital NeuroPEN System is a medical device that received FDA 510(k) clearance on 2024-04-25. It is manufactured by Clarus Medical, LLC. The 510(k) number is K240535.
When was Digital ClarusScope System; Digital NeuroPEN System approved by the FDA?
Digital ClarusScope System; Digital NeuroPEN System received FDA 510(k) clearance on 2024-04-25, under approval number K240535.
What company makes Digital ClarusScope System; Digital NeuroPEN System?
Digital ClarusScope System; Digital NeuroPEN System is manufactured by Clarus Medical, LLC.
What is the FDA product code for Digital ClarusScope System; Digital NeuroPEN System?
The FDA product code for Digital ClarusScope System; Digital NeuroPEN System is HRX.
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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.