C2 Nervemonitor System with Accessories

Q: What is the product code of K111647?

The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.

FDA 510(k) K111647 · Inomed Medizintechnik GmbH

Substantially Equivalent

510(k) numberK111647

Submission

Device name: C2 Nervemonitor System with Accessories
Applicant: Inomed Medizintechnik GmbH
Emmendingen, DE
Received: June 13, 2011
Decision date: October 6, 2011
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GWF – Stimulator, Electrical, Evoked Response
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1870
Specialty: Neurology

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More from Alphatec Spine, Inc.

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K233292	ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Special	10/27/2023SE
K223254	C2 XploreETN · Traditional	01/27/2023SE
K212164	Mapping Suction ProbeETN · Traditional	11/11/2022SE
K212166	ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Traditional	01/07/2022SE
K152505	C2 NerveMonitor SystemETN · Traditional	02/01/2016SE
K091874	Inomed Adhesive Laryngeal Electrodes, Models 530655, 530656ETN · Traditional	11/18/2009SE
K042208	Isis Mer System/Elekta Mer SystemGZL · Traditional	03/18/2005SE
K910972	Walter GraphtekGWQ · Traditional	10/02/1991SE

Questions and answers

When was C2 Nervemonitor System with Accessories cleared by the FDA?

C2 Nervemonitor System with Accessories (K111647) received a 510(k) decision of Substantially Equivalent on October 6, 2011, 115 days after the submission was received.

What is the product code of K111647?

The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.