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)

SEDLINE WITH FRONTAL PSI

K-Number: K033999 · 2004-02-06

ApplicantPhysiometrix, Inc.
Decision Date2004-02-06
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SEDLINE WITH FRONTAL PSI is the device name listed in this FDA 510(k) record. The listed applicant is Physiometrix, Inc.. It received FDA 510(k) clearance on 2004-02-06 under 510(k) number K033999. 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 SEDLINE WITH FRONTAL PSI?

SEDLINE WITH FRONTAL PSI is a medical device that received FDA 510(k) clearance on 2004-02-06. The listed applicant is Physiometrix, Inc.. The 510(k) number is K033999.

When did SEDLINE WITH FRONTAL PSI receive FDA 510(k) clearance?

SEDLINE WITH FRONTAL PSI received FDA 510(k) clearance on 2004-02-06, under 510(k) number K033999.

Who is the listed applicant for SEDLINE WITH FRONTAL PSI?

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

What is the FDA product code for SEDLINE WITH FRONTAL PSI?

The FDA product code for SEDLINE WITH FRONTAL PSI 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Physiometrix, Inc. as applicant

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.

K051874SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SETK020670MODEL 4310 PSARRAY2 EEG ELECTRODEK020671PSA4000 EEG MONITOR WITH FRONTAL PSIK001069MODEL 4000 EEG MONITOR WITH PSI (PSA4000)K001055MODEL 4300 PSARRAY EEG ELECTRODE SETK970942MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM

View all 22 devices →

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, LLCK213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics , Ltd.K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo CorporationK202621NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc.

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.

↑