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)

SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301

K-Number: K042088 · 2004-09-02

ApplicantHeartsine Technologies, Inc.
Decision Date2004-09-02
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 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 2004-09-02 under 510(k) number K042088. 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 SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301?

SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 is a medical device that received FDA 510(k) clearance on 2004-09-02. The listed applicant is Heartsine Technologies, Inc.. The 510(k) number is K042088.

When did SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 receive FDA 510(k) clearance?

SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 received FDA 510(k) clearance on 2004-09-02, under 510(k) number K042088.

Who is the listed applicant for SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301?

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 SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301?

The FDA product code for SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 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 351K041067HEARTSINE SAMARITAN PADK023854SAMARITAN 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.

↑