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FDA 510(k)

A-1050 EEG MONITOR

K-Number: K952347 · 1996-01-16

ApplicantAspect Medical Systems, Inc.
Decision Date1996-01-16
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

A-1050 EEG MONITOR 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 1996-01-16 under 510(k) number K952347. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-1050 EEG MONITOR?

A-1050 EEG MONITOR is a medical device that received FDA 510(k) clearance on 1996-01-16. The listed applicant is Aspect Medical Systems, Inc.. The 510(k) number is K952347.

When did A-1050 EEG MONITOR receive FDA 510(k) clearance?

A-1050 EEG MONITOR received FDA 510(k) clearance on 1996-01-16, under 510(k) number K952347.

Who is the listed applicant for A-1050 EEG MONITOR?

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 A-1050 EEG MONITOR?

The FDA product code for A-1050 EEG MONITOR is OLT.

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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: OLT)

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.

K261712Ceribell EEG Analysis SoftwareCeribell, Inc.K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.K253767UB ERP SystemUniversal BrainK251881HippoMind (v1.0)HippoclinicK251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)Nihon Kohden CorporationK240593VEEGix EEG SystemNeuroServo, 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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