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FDA 510(k)

NURITE II, SINGLE

K-Number: K781683 · 1978-10-13

ApplicantBio-Medical Systems Corp.
Decision Date1978-10-13
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NURITE II, SINGLE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Systems Corp.. It received FDA 510(k) clearance on 1978-10-13 under 510(k) number K781683. 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 NURITE II, SINGLE?

NURITE II, SINGLE is a medical device that received FDA 510(k) clearance on 1978-10-13. The listed applicant is Bio-Medical Systems Corp.. The 510(k) number is K781683.

When did NURITE II, SINGLE receive FDA 510(k) clearance?

NURITE II, SINGLE received FDA 510(k) clearance on 1978-10-13, under 510(k) number K781683.

Who is the listed applicant for NURITE II, SINGLE?

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

What is the FDA product code for NURITE II, SINGLE?

The FDA product code for NURITE II, SINGLE 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 Bio-Medical Systems Corp. 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.

K791834NURITE II VRM DUAL (ELEC. NERVE STIM.)K791833NURITE II VRM SINGLE (ELEC. NERVE STIM)K780828NURITE II

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

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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