DG NERVUS— 510(k) K964280

Substantially Equivalent

Medelec , Ltd.

FDA 510(k) clearance K964280 for DG NERVUS, Substantially Equivalent on 1997-01-27. Applicant: Medelec , Ltd.. Device class: 2.

Clearance details

Applicant: Medelec , Ltd.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1996-10-28
Decision date: 1997-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Old Woking, Surrey, DE

Download summary PDF View on FDA.gov ↗

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Recalls naming K964280

K-number listed on FDA's recall record

Z-0117-2016 — NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography (EcOG), Long Term Monitoring (LTM), Intensive Care Unit (ICU) monitoring and Polysomnography (PSG) Sleep studies. While the Nicolet Neurodiagnostic systems are capable of displaying signals, such as Sp02 and EKG, the system is NOT intended for monitoring such signals for the preservation of life, The Nicolet Neurodiagnostic systems are intended to acquire, analyze, and display dataClass II·Terminated·Natus Neurology Inc·20150911

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964280.

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