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)

EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04

K-Number: K092913 · 2009-10-16

ApplicantEp Medsystems
Decision Date2009-10-16
Product CodeJOQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 is the device name listed in this FDA 510(k) record. The listed applicant is Ep Medsystems. It received FDA 510(k) clearance on 2009-10-16 under 510(k) number K092913. The device is classified under product code JOQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04?

EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 is a medical device that received FDA 510(k) clearance on 2009-10-16. The listed applicant is Ep Medsystems. The 510(k) number is K092913.

When did EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 receive FDA 510(k) clearance?

EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 received FDA 510(k) clearance on 2009-10-16, under 510(k) number K092913.

Who is the listed applicant for EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04?

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

What is the FDA product code for EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04?

The FDA product code for EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 is JOQ.

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 Ep Medsystems 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.

K073709MODIFICATION TO VIEWMATE SYSTEMK071028VIEWMATE SYSTEMK070706EP-WORKMATEK063113EP-WORKMATEK041442EP-4 CLINICAL STIMUTATORK040207EP-4 CLINICAL STIMULATOR

View all 12 devices →

Related Devices (Code: JOQ)

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.

K173439Bloom2 Programmable Electrophysiology StimulatorFischer MedicalK072200STIMLABMicropace Pty, Ltd.K070743Z6 STIMULATORSt Cardio Technologies, LLCK041442EP-4 CLINICAL STIMUTATOREp MedsystemsK040207EP-4 CLINICAL STIMULATOREp MedsystemsK011826EPS320 CARDIAC STIMULATORMicropace Pty, 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.

↑