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510(k) K801670

NDI-IKE EMG by Neurodiagnostics, Inc. — Product Code GWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1980
Date Received
July 22, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conditioner, Signal, Physiological
Device Class
Class II
Regulation Number
882.1845
Review Panel
NE
Submission Type

Other clearances by Neurodiagnostics, Inc.

  • K843253 — EMG/NCV & EVOKED RESPONSE, DESIGN W/ (November 20, 1984)
  • K830191 — NEURO DIAGNOSTICS MODEL FCR (February 18, 1983)
  • K801671 — ESG-1 (EVOKED RESPONSE STIMULUS GENER) (August 4, 1980)

Other clearances for product code GWK

  • K060919 — ACTICAL (September 22, 2006)
  • K061870 — VITALSENSE XHR (August 31, 2006)
  • K052489 — ACTIHEART (September 27, 2005)
  • K991045 — MINI-LOGGER SERIES 2000 (September 21, 1999)
  • K905594 — NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 (June 28, 1991)
  • K904328 — VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM (June 18, 1991)
  • K896164 — ASC-954 INTEGRATOR AMPLIFIER (January 22, 1990)
  • K882599 — NICOLET BRAINLAB SYSTEM (October 19, 1988)
  • K872290 — BIO-LOGIC BANKER (October 6, 1987)
  • K870381 — DD-VCR-64 (March 25, 1987)