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FDA 510(k)

AXION IV GOLDLINE SERIES

K-Number: K862602 · 1986-12-22

ApplicantVentura Medical Electronics
Decision Date1986-12-22
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AXION IV GOLDLINE SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Ventura Medical Electronics. It received FDA 510(k) clearance on 1986-12-22 under 510(k) number K862602. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXION IV GOLDLINE SERIES?

AXION IV GOLDLINE SERIES is a medical device that received FDA 510(k) clearance on 1986-12-22. The listed applicant is Ventura Medical Electronics. The 510(k) number is K862602.

When did AXION IV GOLDLINE SERIES receive FDA 510(k) clearance?

AXION IV GOLDLINE SERIES received FDA 510(k) clearance on 1986-12-22, under 510(k) number K862602.

Who is the listed applicant for AXION IV GOLDLINE SERIES?

The FDA 510(k) record lists Ventura Medical Electronics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXION IV GOLDLINE SERIES?

The FDA product code for AXION IV GOLDLINE SERIES is GZJ.

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 Ventura Medical Electronics 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.

K911814AXION 5, MODIFICATION

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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