K143506

Substantially Equivalent

BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES)

Applicant: Covidien
Product code: GXY
Advisory panel: Neurology
Date received: 2014-12-10
Decision date: 2015-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

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