Home / 510(k) Clearances / K083371

510(k) K083371

NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) by Natus Medical, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2009
Date Received
November 14, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

Other clearances by Natus Medical, Inc.

  • K093304 — PROTEKTOR 32 (August 11, 2010)
  • K093949 — OLYMPIC BRAINZ MONITOR MODEL OBM70001 (June 16, 2010)
  • K090019 — NATUS NEUROWORKS, MODEL 104196 (February 22, 2010)
  • K073665 — ALGO 5 NEWBORN HEARING SCREENER (January 25, 2008)
  • K051869 — NEOBLUE COZY LED PHOTOTHERAPY SYSTEM (October 7, 2005)
  • K030823 — ALGO 3I NEWBORN HEARING SCREENER (April 9, 2003)
  • K022196 — NATUS BLUE LIGHT PHOTOTHERAPY UNIT (September 19, 2002)
  • K013137 — ALGO 3 NEWBORN HEARING SCREENER (October 16, 2001)
  • K974805 — CO-STAT(TM) END TIDAL BREATH ANALYZER (March 11, 1998)
  • K935160 — MINIMUFFS (February 9, 1995)

Other clearances for product code GWF

  • K252842 — SafeOp 3: Neural Informatix System (January 11, 2026)
  • K243982 — Nicolet EDX (January 22, 2025)
  • K243495 — Natus Ultrapro S100 (982A0594) (December 12, 2024)
  • K242345 — Delphi Stimulator (November 5, 2024)
  • K234092 — SafeOp 3: Neural Informatix Systeem (April 19, 2024)
  • K234080 — MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (March 25, 2024)
  • K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (October 27, 2023)
  • K230415 — Cadwell Guardian (August 17, 2023)
  • K213849 — SafeOp 2: Neural Informatix System (March 9, 2022)
  • K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (January 7, 2022)