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FDA 510(k)

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

K-Number: K233292 · 2023-10-27

ApplicantInomed Medizintechnik GmbH
Decision Date2023-10-27
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is a medical device manufactured by Inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 2023-10-27 under approval number K233292. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is a medical device that received FDA 510(k) clearance on 2023-10-27. It is manufactured by Inomed Medizintechnik GmbH. The 510(k) number is K233292.

When was ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress approved by the FDA?

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress received FDA 510(k) clearance on 2023-10-27, under approval number K233292.

What company makes ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is manufactured by Inomed Medizintechnik GmbH.

What is the FDA product code for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

The FDA product code for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is GWF.

Other Devices by Inomed Medizintechnik GmbH

K152505C2 NerveMonitor System K212164Mapping Suction Probe K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress K223254C2 Xplore K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)

Related Devices (Code: GWF)

K160280MagPro R20Tonica Elektronik A/S K170677Neurovision Nerve Locator Monitor (Nerveana), EMGView SoftwareNeurovision Medical Product, Inc. K162873MEP MonitorTonica Elektronik A/S K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. K182542The EPAD 2 SystemSafeop Surgical, Inc. K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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