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)

ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC.

K-Number: K896569 · 1990-01-18

ApplicantJason Marketing Co.
Decision Date1990-01-18
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC. is the device name listed in this FDA 510(k) record. The listed applicant is Jason Marketing Co.. It received FDA 510(k) clearance on 1990-01-18 under 510(k) number K896569. 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 ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC.?

ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC. is a medical device that received FDA 510(k) clearance on 1990-01-18. The listed applicant is Jason Marketing Co.. The 510(k) number is K896569.

When did ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC. receive FDA 510(k) clearance?

ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC. received FDA 510(k) clearance on 1990-01-18, under 510(k) number K896569.

Who is the listed applicant for ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC.?

The FDA 510(k) record lists Jason Marketing Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC.?

The FDA product code for ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC. 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 Jason Marketing Co. 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.

K924133ELECTROTRACE, MODIFICATIONK903555ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC.K894679ELECTROTRACE DISP. RESTING EKG ELECTRODESK871626ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET1200

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.

↑