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FDA 510(k)

BISX

K-Number: K040183 · 2004-02-25

ApplicantAspect Medical Systems, Inc.
Decision Date2004-02-25
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BISX 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 2004-02-25 under 510(k) number K040183. 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 BISX?

BISX is a medical device that received FDA 510(k) clearance on 2004-02-25. The listed applicant is Aspect Medical Systems, Inc.. The 510(k) number is K040183.

When did BISX receive FDA 510(k) clearance?

BISX received FDA 510(k) clearance on 2004-02-25, under 510(k) number K040183.

Who is the listed applicant for BISX?

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 BISX?

The FDA product code for BISX is OLW.

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.

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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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