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510(k) K011823

BIOREHAB SYSTEM by Nicolet Biomedical, Inc. — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2001
Date Received
June 11, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by Nicolet Biomedical, Inc.

  • K020754 — NICOLET PIONEER TC8080 (April 21, 2003)
  • K021986 — BRAINET (August 23, 2002)
  • K021144 — SUBDURAL STRIP ELECTRODE (June 24, 2002)
  • K020218 — SNAP EEG MONITOR (April 22, 2002)
  • K013281 — VERSALAB APM (April 18, 2002)
  • K020955 — NICOLET ELECTROCAUTERY DETECTOR (April 17, 2002)
  • K013419 — NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM (December 20, 2001)
  • K011818 — STERILE EMG ELECTRODES (September 6, 2001)
  • K011135 — GSI AUDERA (July 26, 2001)
  • K010019 — STERILE SUBDERMAL NEEDLE ELECTRODES (March 19, 2001)

Other clearances for product code HCC

  • K233580 — A Breathing System (ABS) (August 1, 2024)
  • K222101 — Prism (March 17, 2023)
  • K180173 — Freespira (August 23, 2018)
  • K163448 — GrindCare System (September 1, 2017)
  • K151050 — Pacifier Activated Lullaby (PAL®) (December 22, 2015)
  • K143507 — NFANT Feeding Solution (September 9, 2015)
  • K131586 — CANARY BREATHING SYSTEM (December 10, 2013)
  • K122879 — EEGER4 MODEL 4.3 (February 6, 2013)
  • K111687 — EMG SYSTEM (September 29, 2011)
  • K092675 — GRINDCARE (March 3, 2010)