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FDA 510(k)

STIMTRAC PC, CATALOG NO. 78-8510

K-Number: K903128 · 1991-01-02

ApplicantStimtech Products
Decision Date1991-01-02
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STIMTRAC PC, CATALOG NO. 78-8510 is the device name listed in this FDA 510(k) record. The listed applicant is Stimtech Products. It received FDA 510(k) clearance on 1991-01-02 under 510(k) number K903128. 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 STIMTRAC PC, CATALOG NO. 78-8510?

STIMTRAC PC, CATALOG NO. 78-8510 is a medical device that received FDA 510(k) clearance on 1991-01-02. The listed applicant is Stimtech Products. The 510(k) number is K903128.

When did STIMTRAC PC, CATALOG NO. 78-8510 receive FDA 510(k) clearance?

STIMTRAC PC, CATALOG NO. 78-8510 received FDA 510(k) clearance on 1991-01-02, under 510(k) number K903128.

Who is the listed applicant for STIMTRAC PC, CATALOG NO. 78-8510?

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

What is the FDA product code for STIMTRAC PC, CATALOG NO. 78-8510?

The FDA product code for STIMTRAC PC, CATALOG NO. 78-8510 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 Stimtech Products 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.

K922562STIMTECH PFX, CATALOG NUMBER 78-8540K895671STIMTRAC II CATALOG NUMBER 78-8500

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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