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FDA 510(k)

PERIPHERAL NERVE STIMULATOR

K-Number: K760614 · 1976-11-19

ApplicantOutput, Inc.
Decision Date1976-11-19
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PERIPHERAL NERVE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Output, Inc.. It received FDA 510(k) clearance on 1976-11-19 under 510(k) number K760614. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIPHERAL NERVE STIMULATOR?

PERIPHERAL NERVE STIMULATOR is a medical device that received FDA 510(k) clearance on 1976-11-19. The listed applicant is Output, Inc.. The 510(k) number is K760614.

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

PERIPHERAL NERVE STIMULATOR received FDA 510(k) clearance on 1976-11-19, under 510(k) number K760614.

Who is the listed applicant for PERIPHERAL NERVE STIMULATOR?

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

What is the FDA product code for PERIPHERAL NERVE STIMULATOR?

The FDA product code for PERIPHERAL NERVE STIMULATOR is BXN.

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 Output, Inc. 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.

K800360OUTPUT DIGITAL DISPLAY MODULE, MOD. 611K781115PRINTER, DIGITALK780356OUTPUT DIGITAL DISPLAY MODULE, MODEL 401K770987NERVE STIMULATOR, MOLEL NO. FB-800

Related Devices (Code: BXN)

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.

K213049STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd.K162086MultiStim ECOPAJUNK GmbH MedizintechnologieK153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorEasy Med Instrument Co., Ltd.K121743EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTINSunmed, LLCK111985MYOGUIDE SYSTEM MODEL 8008Intronix Technologies Corp.K110118STIMTRODE SINGLE USE NERVE STIMULATORXavant Technology (Pty), Ltd.

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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