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FDA 510(k)

DG 3P SYSTEM

K-Number: K934670 · 1994-05-25

ApplicantMedelec , Ltd.
Decision Date1994-05-25
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DG 3P SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medelec , Ltd.. It received FDA 510(k) clearance on 1994-05-25 under 510(k) number K934670. 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 3P SYSTEM?

DG 3P SYSTEM is a medical device that received FDA 510(k) clearance on 1994-05-25. The listed applicant is Medelec , Ltd.. The 510(k) number is K934670.

When did DG 3P SYSTEM receive FDA 510(k) clearance?

DG 3P SYSTEM received FDA 510(k) clearance on 1994-05-25, under 510(k) number K934670.

Who is the listed applicant for DG 3P SYSTEM?

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 3P SYSTEM?

The FDA product code for DG 3P SYSTEM 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. MILLENNIUMK964280DG NERVUSK954157DG PORTABLE SYSTEMK953799DG EXAMINER PLUSK953732TECA PREMIEREK934669ARC

View all 8 devices →

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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