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510(k) K870432

A1-A2 AMBULATORY EEG CASSETTE RECORDER by Grass-Telefactor Product Group — Product Code GWQ

K870432 is an FDA 510(k) premarket notification submitted by Grass-Telefactor Product Group for the device "A1-A2 AMBULATORY EEG CASSETTE RECORDER". The FDA issued a decision of Substantially Equivalent on May 8, 1987. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Grass-Telefactor Product Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1987
Date Received
February 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full-Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

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)
  • K871480 — STD-228 SPECTRAL TREND DISPLAY (May 1, 1987)
  • K870450 — SZAC-16 SEIZURE ANALYSIS COMPUTER (April 8, 1987)
  • K870381 — DD-VCR-64 (March 25, 1987)
  • K860219 — SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM (April 17, 1986)

Other clearances for product code GWQ

  • K261604 — Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (June 13, 2026)
  • K260455 — New Wave System (March 13, 2026)
  • K233403 — Flexset System (April 30, 2024)
  • K231366 — Neuronaute Plus (November 9, 2023)
  • K221959 — Q21 (August 31, 2023)
  • K231457 — SPARK Scan (August 18, 2023)
  • K221963 — Cumulus Functional Neurophysiology Platform (April 27, 2023)
  • K230073 — Okti (February 9, 2023)
  • K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
  • K220056 — iSyncWave (August 10, 2022)

FDA data resources