Bio-Log 8+1 Ambulatory Physiologic Recorder

Q: What is the product code of K864928?

The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.

FDA 510(k) K864928 · Bio-Scan, Inc.

Substantially Equivalent

510(k) numberK864928

Submission

Device name: Bio-Log 8+1 Ambulatory Physiologic Recorder
Applicant: Bio-Scan, Inc.
Dallas, TX, US
Received: December 16, 1986
Decision date: March 31, 1987
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: GWQ – Full-Montage Standard Electroencephalograph
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1400
Specialty: Neurology

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 510(k)s with product code GWQ

510(k)	Device	Applicant	Decision
K261604	Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)GWQ · Special	Neuroelectrics Barcelona S.L.U.	06/13/2026SE
K260455	New Wave SystemGWQ · Special	Zeto, Inc.	03/13/2026SE
K233403	Flexset SystemGWQ · Traditional	Zeto, Inc.	04/30/2024SE
K231366	Neuronaute PlusGWQ · Traditional	Bioserenity Sas	11/09/2023SE
K221959	Q21GWQ · Traditional	Neurofield, Inc.	08/31/2023SE
K231457	SPARK ScanGWQ · Traditional	Spark Neuro, Inc.	08/18/2023SE
K221963	Cumulus Functional Neurophysiology PlatformGWQ · Traditional	Cumulus Neuroscience Limited	04/27/2023SE
K230073	OktiGWQ · Traditional	Compumedics Limited	02/09/2023SE
K223644	Neuronaute with IceCap 2 & IceCap 2 SmallGWQ · Special	Bioserenity	01/12/2023SE
K220056	iSyncWaveGWQ · Traditional	iMediSync, Inc.	08/10/2022SE

More from iMediSync, Inc.

510(k)	Device	Decision
K003480	BiofindGZO · Traditional	05/11/2001SE
K925735	EEG AnalyzerGWS · Traditional	12/03/1993SE
K841685	EEG ElectrodesGXY · Traditional	06/07/1984SE
K841684	Bio/Scan Biolog Cassette RecorderGWQ · Traditional	06/07/1984SE
K841683	Q.P. Preamplifier SysGWQ · Traditional	06/07/1984SE

Questions and answers

When was Bio-Log 8+1 Ambulatory Physiologic Recorder cleared by the FDA?

Bio-Log 8+1 Ambulatory Physiologic Recorder (K864928) received a 510(k) decision of Substantially Equivalent on March 31, 1987, 105 days after the submission was received.

What is the product code of K864928?

The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.