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FDA 510(k)

NDI-IKE EMG

K-Number: K801670 · 1980-08-04

ApplicantNeurodiagnostics, Inc.
Decision Date1980-08-04
Product CodeGWK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NDI-IKE EMG is the device name listed in this FDA 510(k) record. The listed applicant is Neurodiagnostics, Inc.. It received FDA 510(k) clearance on 1980-08-04 under 510(k) number K801670. The device is classified under product code GWK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NDI-IKE EMG?

NDI-IKE EMG is a medical device that received FDA 510(k) clearance on 1980-08-04. The listed applicant is Neurodiagnostics, Inc.. The 510(k) number is K801670.

When did NDI-IKE EMG receive FDA 510(k) clearance?

NDI-IKE EMG received FDA 510(k) clearance on 1980-08-04, under 510(k) number K801670.

Who is the listed applicant for NDI-IKE EMG?

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 NDI-IKE EMG?

The FDA product code for NDI-IKE EMG is GWK.

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.

K843253EMG/NCV & EVOKED RESPONSE, DESIGN W/K830191NEURO DIAGNOSTICS MODEL FCRK801671ESG-1 (EVOKED RESPONSE STIMULUS GENER)

Related Devices (Code: GWK)

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.

K060919ACTICALRespironics, Inc.K061870VITALSENSE XHRRespironics, Inc.K052489ACTIHEARTRespironics, Inc.K991045MINI-LOGGER SERIES 2000Mini-Mitter Co., Inc.K905594NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300Nihon Kohden America, Inc.K904328VISTA POLYSOMNOGRAPHY COMPUTER SYSTEMTelediagnostic Systems, Inc.

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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