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FDA 510(k)

HEARTSINE SAMARITAN PAD

K-Number: K041067 · 2004-05-25

ApplicantHeartsine Technologies, Inc.
Decision Date2004-05-25
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTSINE SAMARITAN PAD is the device name listed in this FDA 510(k) record. The listed applicant is Heartsine Technologies, Inc.. It received FDA 510(k) clearance on 2004-05-25 under 510(k) number K041067. 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 HEARTSINE SAMARITAN PAD?

HEARTSINE SAMARITAN PAD is a medical device that received FDA 510(k) clearance on 2004-05-25. The listed applicant is Heartsine Technologies, Inc.. The 510(k) number is K041067.

When did HEARTSINE SAMARITAN PAD receive FDA 510(k) clearance?

HEARTSINE SAMARITAN PAD received FDA 510(k) clearance on 2004-05-25, under 510(k) number K041067.

Who is the listed applicant for HEARTSINE SAMARITAN PAD?

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

What is the FDA product code for HEARTSINE SAMARITAN PAD?

The FDA product code for HEARTSINE SAMARITAN PAD 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 Heartsine Technologies, 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.

K123881HEARTSINE SAMARITAN PAD 350PK052465REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351K042088SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301K023854SAMARITAN AED, MODEL SAM-01

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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