Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VER MED A10011 PNS DUAL ELEMENT ELECTRODE

K-Number: K921498 · 1993-06-09

ApplicantVermont Medical, Inc.
Decision Date1993-06-09
Product CodeBXM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VER MED A10011 PNS DUAL ELEMENT ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Vermont Medical, Inc.. It received FDA 510(k) clearance on 1993-06-09 under 510(k) number K921498. The device is classified under product code BXM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VER MED A10011 PNS DUAL ELEMENT ELECTRODE?

VER MED A10011 PNS DUAL ELEMENT ELECTRODE is a medical device that received FDA 510(k) clearance on 1993-06-09. The listed applicant is Vermont Medical, Inc.. The 510(k) number is K921498.

When did VER MED A10011 PNS DUAL ELEMENT ELECTRODE receive FDA 510(k) clearance?

VER MED A10011 PNS DUAL ELEMENT ELECTRODE received FDA 510(k) clearance on 1993-06-09, under 510(k) number K921498.

Who is the listed applicant for VER MED A10011 PNS DUAL ELEMENT ELECTRODE?

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

What is the FDA product code for VER MED A10011 PNS DUAL ELEMENT ELECTRODE?

The FDA product code for VER MED A10011 PNS DUAL ELEMENT ELECTRODE is BXM.

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 Vermont Medical, 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.

K030073VERMED A10021 RESTING EKG TAB ELECTRODEK021537MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005K010638NEUROPLUS, MODEL A10040, A10041, A10042, A10043K915831THERMAL PROBE COVERK911687VER-MED A10020 RESTING EKG ELECTRODEK910139VER-MED A10014 RESTING EKG ELECTRODE & A10021

View all 9 devices →

Related Devices (Code: BXM)

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.

K013215MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEMNuvasive, Inc.K002677NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEMNuvasive, Inc.K870662MODEL SKCK STERILE KNOB COVER KITLife-Tech Intl., Inc.

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.

↑