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FDA 510(k)

700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES

K-Number: K970719 · 1997-04-16

ApplicantCardiotronics Systems, Inc.
Decision Date1997-04-16
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

700-MP DISPOSABLE RADIOLUCENT MULTI-PAD 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 1997-04-16 under 510(k) number K970719. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES?

700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES is a medical device that received FDA 510(k) clearance on 1997-04-16. The listed applicant is Cardiotronics Systems, Inc.. The 510(k) number is K970719.

When did 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES receive FDA 510(k) clearance?

700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES received FDA 510(k) clearance on 1997-04-16, under 510(k) number K970719.

Who is the listed applicant for 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD 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-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES?

The FDA product code for 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES is MKJ. This falls under the Dental category.

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 ELECTRODESK964991700-FR SERIES RADIOLUCENT STIMULATION ELECTRODESK964469700-F SERIES STIMULATION ELECTRODES

Related Devices (Code: MKJ)

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.

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical SystemsK131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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