GE ENTROPY SENSOR— 510(k) K082540

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K082540 for GE ENTROPY SENSOR, Substantially Equivalent on 2008-11-28. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code GXY
Advisory panel: Neurology
Date received: 2008-09-02
Decision date: 2008-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

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