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510(k) K870450

SZAC-16 SEIZURE ANALYSIS COMPUTER by Grass-Telefactor Product Group — Product Code OMB

K870450 is an FDA 510(k) premarket notification submitted by Grass-Telefactor Product Group for the device "SZAC-16 SEIZURE ANALYSIS COMPUTER". The FDA issued a decision of Substantially Equivalent on April 8, 1987. The device falls under product code OMB (Automatic Event Detection Software For Full-Montage 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
April 8, 1987
Date Received
February 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user

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)
  • K870381 — DD-VCR-64 (March 25, 1987)
  • K860219 — SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM (April 17, 1986)

Other clearances for product code OMB

  • K260998 — Ceribell Neurology Review Software (June 24, 2026)
  • K252070 — Ceribell Infant Seizure Detection Software (November 21, 2025)
  • K252160 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (October 31, 2025)
  • K241589 — Ceribell Seizure Detection Software (April 9, 2025)
  • K243743 — autoSCORE (V 2.0.0) (April 9, 2025)
  • K242446 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (January 22, 2025)
  • K241390 — NeuroMatch (November 26, 2024)
  • K240408 — REMI-AI Rapid Detection Module (REMI-AI RDM) (October 17, 2024)
  • K240993 — encevis (2.1) (September 27, 2024)
  • K231068 — autoSCORE (January 7, 2024)

FDA data resources