BIS ENGINE— 510(k) K002837

Substantially Equivalent

Aspect Medical Systems, Inc.

FDA 510(k) clearance K002837 for BIS ENGINE, Substantially Equivalent on 2000-09-19. 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: 2000-09-12
Decision date: 2000-09-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Newton, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.