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FDA 510(k)

DG PORTABLE SYSTEM

K-Number: K954157 · 1996-01-17

ApplicantMedelec , Ltd.
Decision Date1996-01-17
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DG PORTABLE 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 1996-01-17 under 510(k) number K954157. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DG PORTABLE SYSTEM?

DG PORTABLE SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-17. The listed applicant is Medelec , Ltd.. The 510(k) number is K954157.

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

DG PORTABLE SYSTEM received FDA 510(k) clearance on 1996-01-17, under 510(k) number K954157.

Who is the listed applicant for DG PORTABLE 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 PORTABLE SYSTEM?

The FDA product code for DG PORTABLE SYSTEM is OLT.

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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 NERVUSK953799DG EXAMINER PLUSK953732TECA PREMIEREK934670DG 3P SYSTEMK934669ARC

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Related Devices (Code: OLT)

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.

K261712Ceribell EEG Analysis SoftwareCeribell, Inc.K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.K253767UB ERP SystemUniversal BrainK251881HippoMind (v1.0)HippoclinicK251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)Nihon Kohden CorporationK240593VEEGix EEG SystemNeuroServo, 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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