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FDA 510(k)

FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS

K-Number: K955628 · 1996-09-10

ApplicantHeartstream, Inc.
Decision Date1996-09-10
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS is the device name listed in this FDA 510(k) record. The listed applicant is Heartstream, Inc.. It received FDA 510(k) clearance on 1996-09-10 under 510(k) number K955628. 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 FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS?

FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS is a medical device that received FDA 510(k) clearance on 1996-09-10. The listed applicant is Heartstream, Inc.. The 510(k) number is K955628.

When did FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS receive FDA 510(k) clearance?

FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS received FDA 510(k) clearance on 1996-09-10, under 510(k) number K955628.

Who is the listed applicant for FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS?

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

What is the FDA product code for FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS?

The FDA product code for FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS 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 Heartstream, 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.

K972418HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)

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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