FDA 510(k)

BIS EEG MONITOR, MODEL A-3000

K-Number: K052362 · 2005-09-09

Decision Date2005-09-09

Product CodeOLW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

BIS EEG MONITOR, MODEL A-3000 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 2005-09-09 under 510(k) number K052362. 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 BIS EEG MONITOR, MODEL A-3000?

BIS EEG MONITOR, MODEL A-3000 is a medical device that received FDA 510(k) clearance on 2005-09-09. The listed applicant is Aspect Medical Systems, Inc.. The 510(k) number is K052362.

When did BIS EEG MONITOR, MODEL A-3000 receive FDA 510(k) clearance?

BIS EEG MONITOR, MODEL A-3000 received FDA 510(k) clearance on 2005-09-09, under 510(k) number K052362.

Who is the listed applicant for BIS EEG MONITOR, MODEL A-3000?

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 EEG MONITOR, MODEL A-3000?

The FDA product code for BIS EEG MONITOR, MODEL A-3000 is OLW.

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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.