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FDA 510(k)

Brain Anesthesia Response Monitor (Bar Monitor)

K-Number: K213273 · 2023-09-01

ApplicantCortical Dynamics , Ltd.
Decision Date2023-09-01
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Brain Anesthesia Response Monitor (Bar Monitor) is a medical device manufactured by Cortical Dynamics , Ltd.. It received FDA 510(k) clearance on 2023-09-01 under approval number K213273. The device is classified under product code OLW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Brain Anesthesia Response Monitor (Bar Monitor)?

Brain Anesthesia Response Monitor (Bar Monitor) is a medical device that received FDA 510(k) clearance on 2023-09-01. It is manufactured by Cortical Dynamics , Ltd.. The 510(k) number is K213273.

When was Brain Anesthesia Response Monitor (Bar Monitor) approved by the FDA?

Brain Anesthesia Response Monitor (Bar Monitor) received FDA 510(k) clearance on 2023-09-01, under approval number K213273.

What company makes Brain Anesthesia Response Monitor (Bar Monitor)?

Brain Anesthesia Response Monitor (Bar Monitor) is manufactured by Cortical Dynamics , Ltd..

What is the FDA product code for Brain Anesthesia Response Monitor (Bar Monitor)?

The FDA product code for Brain Anesthesia Response Monitor (Bar Monitor) is OLW.

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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.

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