510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K071109Substantially Equivalent

Sacs EEG Workstation A7

Sacs Medical AB, Eugene OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071109 is the FDA 510(k) clearance record for SACS EEG WORKSTATION A7, a class II device, cleared for Sacs Medical AB on under FDA product code GWQ (Full-Montage Standard Electroencephalograph). FDA's definition for product code GWQ reads: "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". FDA records list one 510(k) clearance for Sacs Medical AB. As of , FDA records show no recalls naming K071109.

Clearance record

Decision date
Received
(50 days to decision)
Product code
GWQ Full-Montage Standard Electroencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Sacs Medical AB 3684 N. Shasta Loop, Eugene OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWQ

Trailing 12 months
2 clearances under product code GWQ in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260