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FDA 510(k)

EEG MIS MONITOR MODEL # A-2000; BIS ENGINE

K-Number: K011534 · 2001-06-15

ApplicantAspect Medical Systems, Inc.
Decision Date2001-06-15
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EEG MIS MONITOR MODEL # A-2000; BIS ENGINE is the device name listed in this FDA 510(k) record. The listed applicant is Aspect Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-06-15 under 510(k) number K011534. 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 EEG MIS MONITOR MODEL # A-2000; BIS ENGINE?

EEG MIS MONITOR MODEL # A-2000; BIS ENGINE is a medical device that received FDA 510(k) clearance on 2001-06-15. The listed applicant is Aspect Medical Systems, Inc.. The 510(k) number is K011534.

When did EEG MIS MONITOR MODEL # A-2000; BIS ENGINE receive FDA 510(k) clearance?

EEG MIS MONITOR MODEL # A-2000; BIS ENGINE received FDA 510(k) clearance on 2001-06-15, under 510(k) number K011534.

Who is the listed applicant for EEG MIS MONITOR MODEL # A-2000; BIS ENGINE?

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

What is the FDA product code for EEG MIS MONITOR MODEL # A-2000; BIS ENGINE?

The FDA product code for EEG MIS MONITOR MODEL # A-2000; BIS ENGINE is OLW.

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Other records listing Aspect Medical Systems, 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.

K093183BIS QUATRO SENSORK091854BIS CLICK SENSOR/CABLEK072286BIS EEG VISTA MONITOR SYSTEM AND BISXK062613BIS EEG MONITOR VIEWK070069ZIPPREP ELECTRODEK062692BIS BILATERAL SENSOR

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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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