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FDA 510(k)

STIMULATOR, NERVE, TRANSCUTANEOUS

K-Number: K781277 · 1978-09-27

ApplicantPsitron
Decision Date1978-09-27
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STIMULATOR, NERVE, TRANSCUTANEOUS is the device name listed in this FDA 510(k) record. The listed applicant is Psitron. It received FDA 510(k) clearance on 1978-09-27 under 510(k) number K781277. 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 STIMULATOR, NERVE, TRANSCUTANEOUS?

STIMULATOR, NERVE, TRANSCUTANEOUS is a medical device that received FDA 510(k) clearance on 1978-09-27. The listed applicant is Psitron. The 510(k) number is K781277.

When did STIMULATOR, NERVE, TRANSCUTANEOUS receive FDA 510(k) clearance?

STIMULATOR, NERVE, TRANSCUTANEOUS received FDA 510(k) clearance on 1978-09-27, under 510(k) number K781277.

Who is the listed applicant for STIMULATOR, NERVE, TRANSCUTANEOUS?

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

What is the FDA product code for STIMULATOR, NERVE, TRANSCUTANEOUS?

The FDA product code for STIMULATOR, NERVE, TRANSCUTANEOUS 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 Psitron 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.

K823334PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630

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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