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FDA 510(k)

BIS SRS (SEMI-RESUABLE SENSOR)

K-Number: K050313 · 2005-02-24

ApplicantAspect Medical Systems, Inc.
Decision Date2005-02-24
Product CodeGWY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIS SRS (SEMI-RESUABLE SENSOR) 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 2005-02-24 under 510(k) number K050313. The device is classified under product code GWY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIS SRS (SEMI-RESUABLE SENSOR)?

BIS SRS (SEMI-RESUABLE SENSOR) is a medical device that received FDA 510(k) clearance on 2005-02-24. The listed applicant is Aspect Medical Systems, Inc.. The 510(k) number is K050313.

When did BIS SRS (SEMI-RESUABLE SENSOR) receive FDA 510(k) clearance?

BIS SRS (SEMI-RESUABLE SENSOR) received FDA 510(k) clearance on 2005-02-24, under 510(k) number K050313.

Who is the listed applicant for BIS SRS (SEMI-RESUABLE SENSOR)?

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 BIS SRS (SEMI-RESUABLE SENSOR)?

The FDA product code for BIS SRS (SEMI-RESUABLE SENSOR) is GWY.

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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: GWY)

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.

K942926NEURO-AIDEBurke Neutech, Inc.K871167SENSITESTERDexin Pty. , Ltd.K8517491-380 PINWHEEL (WARTENBERG)ArtiberiaK780422PINWHEELProjects IN Health

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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