Decision Date2016-02-01
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
C2 NerveMonitor System 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 2016-02-01 under 510(k) 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. The listed applicant is Inomed Medizintechnik GmbH. The 510(k) number is K152505.
When did C2 NerveMonitor System receive FDA 510(k) clearance?
C2 NerveMonitor System received FDA 510(k) clearance on 2016-02-01, under 510(k) number K152505.
Who is the listed applicant for C2 NerveMonitor System?
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?
The FDA product code for C2 NerveMonitor System is ETN.
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Related Devices (Code: ETN)
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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.