Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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.

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. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06732050Influence of Intraoperative Nociception Guided Analgesia on Perioperative Total Analgesic Requirement EndometriosisCOMPLETEDNCT06817005Nociception Monitoring During Cardiac SurgeryCOMPLETEDNCT07510451The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic SurgeryRECRUITINGNCT07571473CoreSys Monitoring for Intraoperative Stress Management in Abdominal HysterectomyRECRUITINGNCT07696910Perioperative Hypoglycemia in Diabetic Patients Undergoing Vitrectomy: a Masked CGM Prospective Observational StudyNOT_YET_RECRUITING

Related Devices (Code: OLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260907BIS™ Advance pEEG ModuleCovidien LPK260880SedLine Sedation MonitorMasimo CorporationK230693BIS™ Advance Monitoring SystemCovidien, LLCK203113Masimo SedLine Sedation Monitor and AccessoriesMasimo CorporationK202621NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc.K172890SedLine Sedation MonitorMasimo Corporation

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.

↑