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FDA 510(k)

ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR

K-Number: K961821 · 1996-10-04

ApplicantAspect Medical Systems, Inc.
Decision Date1996-10-04
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ASPECT MEDICAL SYSTEMS ZIPPREP EEG 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 1996-10-04 under 510(k) number K961821. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR?

ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR is a medical device that received FDA 510(k) clearance on 1996-10-04. The listed applicant is Aspect Medical Systems, Inc.. The 510(k) number is K961821.

When did ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR receive FDA 510(k) clearance?

ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR received FDA 510(k) clearance on 1996-10-04, under 510(k) number K961821.

Who is the listed applicant for ASPECT MEDICAL SYSTEMS ZIPPREP EEG 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 ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR?

The FDA product code for ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR is GXY.

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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: GXY)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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