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)

BIO-SENSOR 01 EKG ELECTRODE

K-Number: K911472 · 1991-10-10

ApplicantBio-Sensor, Inc.
Decision Date1991-10-10
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIO-SENSOR 01 EKG ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Sensor, Inc.. It received FDA 510(k) clearance on 1991-10-10 under 510(k) number K911472. 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 BIO-SENSOR 01 EKG ELECTRODE?

BIO-SENSOR 01 EKG ELECTRODE is a medical device that received FDA 510(k) clearance on 1991-10-10. The listed applicant is Bio-Sensor, Inc.. The 510(k) number is K911472.

When did BIO-SENSOR 01 EKG ELECTRODE receive FDA 510(k) clearance?

BIO-SENSOR 01 EKG ELECTRODE received FDA 510(k) clearance on 1991-10-10, under 510(k) number K911472.

Who is the listed applicant for BIO-SENSOR 01 EKG ELECTRODE?

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

What is the FDA product code for BIO-SENSOR 01 EKG ELECTRODE?

The FDA product code for BIO-SENSOR 01 EKG ELECTRODE 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

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.

↑