BIS PEDIATRIC SENSOR— 510(k) K041670

Substantially Equivalent

Aspect Medical Systems, Inc.

FDA 510(k) clearance K041670 for BIS PEDIATRIC SENSOR, Substantially Equivalent on 2004-07-06. Applicant: Aspect Medical Systems, Inc..

Clearance details

Applicant: Aspect Medical Systems, Inc.
Product code: Code GXY
Advisory panel: Neurology
Date received: 2004-06-21
Decision date: 2004-07-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Newton, MA, US

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