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Bis Standard Sensor, 1-Channel (3 Electrodes) +6 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K143506

by Covidien

Identifiers

510(k) Number
K143506 FDA 510(k)
FDA Product Code
GXY FDA 510(k)
Models / Variants
Bis Standard Sensor, 1-Channel (3 Electrodes) FDA 510(k)
Bis Pedi Sensor, 1-Channel, 3 Electrodes FDA 510(k)
Bis Quatro Sensor FDA 510(k)
Bis Pedi-Xp Sensor, 2-Channel (4 Electrodes) FDA 510(k)
Bis Extend Sensor FDA 510(k)
Bis Bilateral Sensor, 4-Channel (6 Elecrodes) FDA 510(k)
Bis Insight Sensor, Cvi-Enabled, 2-Channel (4 Electrodes) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1320 FDA 510(k)
Regulation Number
882.1320 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Bis Standard Sensor, 1-Channel (3 Electrodes) +6 more models by Covidien — Class II — FDA_510K — listed in FDA 510(k) — 7 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Covidien

Sources (1)

  • FDA 510(k) K143506 24 fields · synced Jun 18, 2026