MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000— 510(k) K031694

Name: FDA 510(k) clearance K031694
Creator: U.S. Food and Drug Administration
Published: 2003-08-29

Substantially Equivalent

Aspect Medical Systems, Inc.

FDA 510(k) clearance K031694 for MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000, Substantially Equivalent on 2003-08-29. 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: 2003-06-02
Decision date: 2003-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, CO, US

Download summary PDF View on FDA.gov ↗

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