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510(k) K103140

NICOLET WIRELESS EEG by Carefusion 209, Inc. — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2011
Date Received
October 25, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type

Other clearances by Carefusion 209, Inc.

  • K120979 — CAREFUSION NICOLET EDX (April 25, 2012)
  • K112052 — CAREFUSION NICOLET EDX (March 15, 2012)
  • K112034 — TECA ELITE DISPOSABLE CONCENTRIC NEEDLES (August 12, 2011)
  • K111131 — TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES (June 17, 2011)

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  • K240646 — DreamClear (September 4, 2024)
  • K232210 — X-trodes System M (February 4, 2024)
  • K230148 — Vlab (October 11, 2023)
  • K223676 — SomniCheck (June 1, 2023)
  • K220631 — NomadAir PMU810 (July 15, 2022)
  • K203331 — Quick-20m (May 20, 2021)
  • K202174 — Digital NeuroPort Biopotential Signal Processing System (February 10, 2021)