BIS EEG MONITOR, MODEL A-3000— 510(k) K052362

Name: FDA 510(k) clearance K052362
Creator: U.S. Food and Drug Administration
Published: 2005-09-09

Substantially Equivalent

Aspect Medical Systems, Inc.

FDA 510(k) clearance K052362 for BIS EEG MONITOR, MODEL A-3000, Substantially Equivalent on 2005-09-09. Applicant: Aspect Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Aspect Medical Systems, Inc.
Product code: Code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2005-08-29
Decision date: 2005-09-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Newton, MA, US

Download summary PDF View on FDA.gov ↗

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