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FDA 510(k)

C2 NerveMonitor System

K-Number: K152505 · 2016-02-01

ApplicantInomed Medizintechnik GmbH
Decision Date2016-02-01
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

C2 NerveMonitor System is a medical device manufactured by Inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 2016-02-01 under approval number K152505. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C2 NerveMonitor System?

C2 NerveMonitor System is a medical device that received FDA 510(k) clearance on 2016-02-01. It is manufactured by Inomed Medizintechnik GmbH. The 510(k) number is K152505.

When was C2 NerveMonitor System approved by the FDA?

C2 NerveMonitor System received FDA 510(k) clearance on 2016-02-01, under approval number K152505.

What company makes C2 NerveMonitor System?

C2 NerveMonitor System is manufactured by Inomed Medizintechnik GmbH.

What is the FDA product code for C2 NerveMonitor System?

The FDA product code for C2 NerveMonitor System is ETN.

Other Devices by Inomed Medizintechnik GmbH

K212164Mapping Suction Probe K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress K233292ISIS 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: ETN)

K152769FREMAP ELECTRODEAd-Tech Medical Instrument Corporation K200886StimSiteAllotrope Medical, Inc. K212355Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, LargeCheckpoint Surgical K212164Mapping Suction ProbeInomed Medizintechnik GmbH K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm LongMedtronic Xomed, Inc. K232888Disposable Laryngeal ElectrodesSuzhou Haishen Medical Device Associates Co., Ltd.

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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