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FDA 510(k)

TRANSAMERICA ELECTRODE

K-Number: K961749 · 1996-06-21

ApplicantTransamerica Medical Systems
Decision Date1996-06-21
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TRANSAMERICA ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Transamerica Medical Systems. It received FDA 510(k) clearance on 1996-06-21 under 510(k) number K961749. 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 TRANSAMERICA ELECTRODE?

TRANSAMERICA ELECTRODE is a medical device that received FDA 510(k) clearance on 1996-06-21. The listed applicant is Transamerica Medical Systems. The 510(k) number is K961749.

When did TRANSAMERICA ELECTRODE receive FDA 510(k) clearance?

TRANSAMERICA ELECTRODE received FDA 510(k) clearance on 1996-06-21, under 510(k) number K961749.

Who is the listed applicant for TRANSAMERICA ELECTRODE?

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

What is the FDA product code for TRANSAMERICA ELECTRODE?

The FDA product code for TRANSAMERICA ELECTRODE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Transamerica Medical Systems 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.

K010665TRANSAMERICA DIGITAL EMSK010782TRANSAMERICAN TENS

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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