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FDA 510(k)

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

K-Number: K972418 · 1997-09-25

ApplicantHeartstream, Inc.
Decision Date1997-09-25
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX) is the device name listed in this FDA 510(k) record. The listed applicant is Heartstream, Inc.. It received FDA 510(k) clearance on 1997-09-25 under 510(k) number K972418. 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 HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)?

HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX) is a medical device that received FDA 510(k) clearance on 1997-09-25. The listed applicant is Heartstream, Inc.. The 510(k) number is K972418.

When did HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX) receive FDA 510(k) clearance?

HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX) received FDA 510(k) clearance on 1997-09-25, under 510(k) number K972418.

Who is the listed applicant for HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)?

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

The FDA product code for HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX) 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.

K955628FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS

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

View on FDA Database →

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

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