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 A10014 RESTING EKG ELECTRODE & A10021

K-Number: K910139 · 1991-08-15

ApplicantVermont Medical, Inc.
Decision Date1991-08-15
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VER-MED A10014 RESTING EKG ELECTRODE & A10021 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 1991-08-15 under 510(k) number K910139. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VER-MED A10014 RESTING EKG ELECTRODE & A10021?

VER-MED A10014 RESTING EKG ELECTRODE & A10021 is a medical device that received FDA 510(k) clearance on 1991-08-15. The listed applicant is Vermont Medical, Inc.. The 510(k) number is K910139.

When did VER-MED A10014 RESTING EKG ELECTRODE & A10021 receive FDA 510(k) clearance?

VER-MED A10014 RESTING EKG ELECTRODE & A10021 received FDA 510(k) clearance on 1991-08-15, under 510(k) number K910139.

Who is the listed applicant for VER-MED A10014 RESTING EKG ELECTRODE & A10021?

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 A10014 RESTING EKG ELECTRODE & A10021?

The FDA product code for VER-MED A10014 RESTING EKG ELECTRODE & A10021 is DRX.

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, A10043K921498VER MED A10011 PNS DUAL ELEMENT ELECTRODEK915831THERMAL PROBE COVERK911687VER-MED A10020 RESTING EKG ELECTRODE

View all 9 devices →

Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., 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.

↑