SACS EEG Workstation A7

by Sacs Medical AB

510(k) K071109

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K071109↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK071109	Date7 Jun 2007Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K071109
FDA Product Code: GWQ

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 SACS EEG Workstation A7 is a full-montage standard electroencephalograph device intended for the measurement and recording of electrical activity in a patient's brain using electrodes placed on the patient's head. It is designed for use by qualified medical personnel trained in electroencephalograph operation.

The device is supplied as a workstation system and is intended for single-patient use. It is regulated under FDA 510(k) clearance with product code GWQ and classification as a full-montage standard electroencephalograph. The device is authorized for use in neurology applications and was cleared as substantially equivalent on June 7, 2007.