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FDA 510(k)

SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET

K-Number: K051874 · 2005-09-02

ApplicantPhysiometrix, Inc.
Decision Date2005-09-02
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET is the device name listed in this FDA 510(k) record. The listed applicant is Physiometrix, Inc.. It received FDA 510(k) clearance on 2005-09-02 under 510(k) number K051874. 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 SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET?

SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET is a medical device that received FDA 510(k) clearance on 2005-09-02. The listed applicant is Physiometrix, Inc.. The 510(k) number is K051874.

When did SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET receive FDA 510(k) clearance?

SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET received FDA 510(k) clearance on 2005-09-02, under 510(k) number K051874.

Who is the listed applicant for SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET?

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 SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET?

The FDA product code for SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET is OLW.

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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.

K033999SEDLINE WITH FRONTAL PSIK020670MODEL 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

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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.

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