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FDA 510(k)

C2 NERVEMONITOR SYSTEM WITH ACCESSORIES

K-Number: K111647 · 2011-10-06

ApplicantInomed Medizintechnik GmbH
Decision Date2011-10-06
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

C2 NERVEMONITOR SYSTEM WITH ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 2011-10-06 under 510(k) number K111647. 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 C2 NERVEMONITOR SYSTEM WITH ACCESSORIES?

C2 NERVEMONITOR SYSTEM WITH ACCESSORIES is a medical device that received FDA 510(k) clearance on 2011-10-06. The listed applicant is Inomed Medizintechnik GmbH. The 510(k) number is K111647.

When did C2 NERVEMONITOR SYSTEM WITH ACCESSORIES receive FDA 510(k) clearance?

C2 NERVEMONITOR SYSTEM WITH ACCESSORIES received FDA 510(k) clearance on 2011-10-06, under 510(k) number K111647.

Who is the listed applicant for C2 NERVEMONITOR SYSTEM WITH ACCESSORIES?

The FDA 510(k) record lists Inomed Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C2 NERVEMONITOR SYSTEM WITH ACCESSORIES?

The FDA product code for C2 NERVEMONITOR SYSTEM WITH ACCESSORIES is GWF.

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Other records listing Inomed Medizintechnik GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressK242852ALM 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)K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressK223254C2 XploreK212164Mapping Suction ProbeK212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

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Related Devices (Code: GWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx Neuroscience

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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