BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES) +6 more— 510(k) K143506
Substantially EquivalentCovidien
FDA 510(k) clearance K143506 for BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES) +6 more, Substantially Equivalent on 2015-04-16. Applicant: Covidien. Device class: 2.
Clearance details
- Device name as filed
- 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
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.