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FDA 510(k)

MODEL 4000 EEG MONITOR WITH PSI (PSA4000)

K-Number: K001069 · 2000-06-30

ApplicantPhysiometrix, Inc.
Decision Date2000-06-30
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL 4000 EEG MONITOR WITH PSI (PSA4000) is the device name listed in this FDA 510(k) record. The listed applicant is Physiometrix, Inc.. It received FDA 510(k) clearance on 2000-06-30 under 510(k) number K001069. 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 MODEL 4000 EEG MONITOR WITH PSI (PSA4000)?

MODEL 4000 EEG MONITOR WITH PSI (PSA4000) is a medical device that received FDA 510(k) clearance on 2000-06-30. The listed applicant is Physiometrix, Inc.. The 510(k) number is K001069.

When did MODEL 4000 EEG MONITOR WITH PSI (PSA4000) receive FDA 510(k) clearance?

MODEL 4000 EEG MONITOR WITH PSI (PSA4000) received FDA 510(k) clearance on 2000-06-30, under 510(k) number K001069.

Who is the listed applicant for MODEL 4000 EEG MONITOR WITH PSI (PSA4000)?

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 MODEL 4000 EEG MONITOR WITH PSI (PSA4000)?

The FDA product code for MODEL 4000 EEG MONITOR WITH PSI (PSA4000) 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.

K051874SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SETK033999SEDLINE WITH FRONTAL PSIK020670MODEL 4310 PSARRAY2 EEG ELECTRODEK020671PSA4000 EEG MONITOR WITH FRONTAL PSIK001055MODEL 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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