A-2000 EEG MONITOR WITH BIS— 510(k) K974496

Name: FDA 510(k) clearance K974496
Creator: U.S. Food and Drug Administration
Published: 1998-02-06

Substantially Equivalent

Aspect Medical Systems, Inc.

FDA 510(k) clearance K974496 for A-2000 EEG MONITOR WITH BIS, Substantially Equivalent on 1998-02-06. 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: 1997-11-28
Decision date: 1998-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, US

Download summary PDF View on FDA.gov ↗

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