EEG MIS MONITOR MODEL # A-2000; BIS ENGINE— 510(k) K011534

Name: FDA 510(k) clearance K011534
Creator: U.S. Food and Drug Administration
Published: 2001-06-15

Substantially Equivalent

Aspect Medical Systems, Inc.

FDA 510(k) clearance K011534 for EEG MIS MONITOR MODEL # A-2000; BIS ENGINE, Substantially Equivalent on 2001-06-15. 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: 2001-05-18
Decision date: 2001-06-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Newton, MA, US

Download summary PDF View on FDA.gov ↗

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