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FDA 510(k)

NEURO DIAGNOSTICS MODEL FCR

K-Number: K830191 · 1983-02-18

ApplicantNeurodiagnostics, Inc.
Decision Date1983-02-18
Product CodeGWK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEURO DIAGNOSTICS MODEL FCR is the device name listed in this FDA 510(k) record. The listed applicant is Neurodiagnostics, Inc.. It received FDA 510(k) clearance on 1983-02-18 under 510(k) number K830191. 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 NEURO DIAGNOSTICS MODEL FCR?

NEURO DIAGNOSTICS MODEL FCR is a medical device that received FDA 510(k) clearance on 1983-02-18. The listed applicant is Neurodiagnostics, Inc.. The 510(k) number is K830191.

When did NEURO DIAGNOSTICS MODEL FCR receive FDA 510(k) clearance?

NEURO DIAGNOSTICS MODEL FCR received FDA 510(k) clearance on 1983-02-18, under 510(k) number K830191.

Who is the listed applicant for NEURO DIAGNOSTICS MODEL FCR?

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 NEURO DIAGNOSTICS MODEL FCR?

The FDA product code for NEURO DIAGNOSTICS MODEL FCR is GWK.

Related Clinical Trials

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.

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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.

K843253EMG/NCV & EVOKED RESPONSE, DESIGN W/K801671ESG-1 (EVOKED RESPONSE STIMULUS GENER)K801670NDI-IKE EMG

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

View on FDA Database →

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

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