FDA 510(k), K161893, Neuromonitoring Kit

FDA 510(k), K161893, Neuromonitoring Kit

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510(K) Number: K161893
Device Name: Neuromonitoring Kit
Manufacturer: ROXANNE DUBOIS
Device Classification Name: Neurosurgical Nerve Locator
Regulation Number: PDQ
Classification Product Code: 07/11/2016
Date Received: 10/18/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology

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