Neuronaute with IceCap 2 & IceCap 2 Small

Q: What is the product code of K223644?

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) K223644 · Bioserenity

Substantially Equivalent

510(k) numberK223644

Submission

Device name: Neuronaute with IceCap 2 & IceCap 2 Small
Applicant: Bioserenity
Paris, FR
Received: December 6, 2022
Decision date: January 12, 2023
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

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
K220056	iSyncWaveGWQ · Traditional	iMediSync, Inc.	08/10/2022SE
K212788	Seer HomeGWQ · Traditional	Seer Medical Pty, Ltd.	06/16/2022SE

More from Seer Medical Pty, Ltd.

510(k)	Device	Decision
K231366	Neuronaute PlusGWQ · Traditional	11/09/2023SE
K202334	NeuronauteGWQ · Traditional	12/10/2020SE
K173248	CardioskinDXH · Traditional	08/11/2018SE
K170138	NeuronauteGWQ · Traditional	12/26/2017SE

Questions and answers

When was Neuronaute with IceCap 2 & IceCap 2 Small cleared by the FDA?

Neuronaute with IceCap 2 & IceCap 2 Small (K223644) received a 510(k) decision of Substantially Equivalent on January 12, 2023, 37 days after the submission was received.

What is the product code of K223644?

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