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510(k) K870381

DD-VCR-64 by Grass-Telefactor Product Group — Product Code GWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1987
Date Received
January 29, 1987
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 Grass-Telefactor Product Group

  • K992291 — H20- TETHERED OPTION (August 6, 1999)
  • K974583 — DEEGLITE (June 9, 1998)
  • K974587 — H2O (March 9, 1998)
  • K972202 — DEEG-LITE (July 23, 1997)
  • K925838 — TELEFACTOR D/EEG-32 (April 30, 1993)
  • K884937 — BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING (April 14, 1989)
  • K870432 — A1-A2 AMBULATORY EEG CASSETTE RECORDER (May 8, 1987)
  • K871480 — STD-228 SPECTRAL TREND DISPLAY (May 1, 1987)
  • K870450 — SZAC-16 SEIZURE ANALYSIS COMPUTER (April 8, 1987)
  • K860219 — SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM (April 17, 1986)

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)
  • K860914 — ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV (June 6, 1986)