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)

700-F SERIES STIMULATION ELECTRODES

K-Number: K964469 · 1996-12-11

ApplicantCardiotronics Systems, Inc.
Decision Date1996-12-11
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

700-F SERIES STIMULATION ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Cardiotronics Systems, Inc.. It received FDA 510(k) clearance on 1996-12-11 under 510(k) number K964469. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 700-F SERIES STIMULATION ELECTRODES?

700-F SERIES STIMULATION ELECTRODES is a medical device that received FDA 510(k) clearance on 1996-12-11. The listed applicant is Cardiotronics Systems, Inc.. The 510(k) number is K964469.

When did 700-F SERIES STIMULATION ELECTRODES receive FDA 510(k) clearance?

700-F SERIES STIMULATION ELECTRODES received FDA 510(k) clearance on 1996-12-11, under 510(k) number K964469.

Who is the listed applicant for 700-F SERIES STIMULATION ELECTRODES?

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

What is the FDA product code for 700-F SERIES STIMULATION ELECTRODES?

The FDA product code for 700-F SERIES STIMULATION ELECTRODES is LDD.

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 Cardiotronics Systems, 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.

K971148700-SP SERIES DISPOSABLE STIMULATION ELECTRODESK970719700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODESK964991700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES

Related Devices (Code: LDD)

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.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, 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.

↑