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SZAC-16 Seizure Analysis Computer

by Grass-Telefactor Product Group

510(k) K870450

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870450 Date8 Apr 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OMB
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Szac-16 Seizure Analysis Computer is an automatic event detection software for full-montage electroencephalograph, classified under the medical specialty of Neurology. It is designed to analyze seizures and provide detection software for electroencephalograph events. The device is substantially equivalent and falls under the regulation number 882.1400. The Szac-16 Seizure Analysis Computer is a type of computer software used in neurology for seizure analysis.

The Szac-16 Seizure Analysis Computer is supplied by Grass-Telefactor Product Group and has been assigned the product code OMB. It has received FDA 510(k) clearance with the clearance type being traditional. The device has a specific regulation number and is classified as a class 2 device. The Szac-16 Seizure Analysis Computer is used in the field of neurology and has a unique k number, K870450.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SZAC-16 Seizure Analysis Computer used for?

    The SZAC-16 Seizure Analysis Computer is used for analyzing seizures and detecting electroencephalograph events in the field of neurology.

  • What type of clearance has the SZAC-16 Seizure Analysis Computer received?

    The SZAC-16 Seizure Analysis Computer has received FDA 510(k) clearance with a traditional clearance type.

  • What is the classification of the SZAC-16 Seizure Analysis Computer?

    The SZAC-16 Seizure Analysis Computer is classified as a class 2 device under the regulation number 882.1400.

  • Who is the manufacturer of the SZAC-16 Seizure Analysis Computer?

    The SZAC-16 Seizure Analysis Computer is supplied by Grass-Telefactor Product Group.