FDA 510(k)

Brain Anesthesia Response Monitor (Bar Monitor)

Número K: K213273 · 2023-09-01

Data da decisão2023-09-01

Código do produtoOLW

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Cortical Dynamics , Ltd.. The 510(k) number is K213273.

When did Brain Anesthesia Response Monitor (Bar Monitor) receive FDA 510(k) clearance?

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

Who is the listed applicant for Brain Anesthesia Response Monitor (Bar Monitor)?

The FDA 510(k) record lists Cortical Dynamics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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