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FDA 510(k)

EMG/NCV & EVOKED RESPONSE, DESIGN W/

K-Number: K843253 · 1984-11-20

ApplicantNeurodiagnostics, Inc.
Decision Date1984-11-20
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMG/NCV & EVOKED RESPONSE, DESIGN W/ is the device name listed in this FDA 510(k) record. The listed applicant is Neurodiagnostics, Inc.. It received FDA 510(k) clearance on 1984-11-20 under 510(k) number K843253. 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 EMG/NCV & EVOKED RESPONSE, DESIGN W/?

EMG/NCV & EVOKED RESPONSE, DESIGN W/ is a medical device that received FDA 510(k) clearance on 1984-11-20. The listed applicant is Neurodiagnostics, Inc.. The 510(k) number is K843253.

When did EMG/NCV & EVOKED RESPONSE, DESIGN W/ receive FDA 510(k) clearance?

EMG/NCV & EVOKED RESPONSE, DESIGN W/ received FDA 510(k) clearance on 1984-11-20, under 510(k) number K843253.

Who is the listed applicant for EMG/NCV & EVOKED RESPONSE, DESIGN W/?

The FDA 510(k) record lists Neurodiagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMG/NCV & EVOKED RESPONSE, DESIGN W/?

The FDA product code for EMG/NCV & EVOKED RESPONSE, DESIGN W/ is GWF.

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Other records listing Neurodiagnostics, Inc. 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.

K830191NEURO DIAGNOSTICS MODEL FCRK801671ESG-1 (EVOKED RESPONSE STIMULUS GENER)K801670NDI-IKE EMG

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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