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FDA 510(k)

DG NERVUS

K-Number: K964280 · 1997-01-27

ApplicantMedelec , Ltd.
Decision Date1997-01-27
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DG NERVUS is the device name listed in this FDA 510(k) record. The listed applicant is Medelec , Ltd.. It received FDA 510(k) clearance on 1997-01-27 under 510(k) number K964280. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DG NERVUS?

DG NERVUS is a medical device that received FDA 510(k) clearance on 1997-01-27. The listed applicant is Medelec , Ltd.. The 510(k) number is K964280.

When did DG NERVUS receive FDA 510(k) clearance?

DG NERVUS received FDA 510(k) clearance on 1997-01-27, under 510(k) number K964280.

Who is the listed applicant for DG NERVUS?

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

What is the FDA product code for DG NERVUS?

The FDA product code for DG NERVUS is GWQ.

Related Clinical Trials

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Other records listing Medelec , Ltd. 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.

K965065TECA. MILLENNIUMK954157DG PORTABLE SYSTEMK953799DG EXAMINER PLUSK953732TECA PREMIEREK934670DG 3P SYSTEMK934669ARC

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Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, 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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