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FDA 510(k)

PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS

K-Number: K003548 · 2001-09-04

ApplicantPadpro, LLC
Decision Date2001-09-04
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS is the device name listed in this FDA 510(k) record. The listed applicant is Padpro, LLC. It received FDA 510(k) clearance on 2001-09-04 under 510(k) number K003548. 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 PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS?

PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS is a medical device that received FDA 510(k) clearance on 2001-09-04. The listed applicant is Padpro, LLC. The 510(k) number is K003548.

When did PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS receive FDA 510(k) clearance?

PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS received FDA 510(k) clearance on 2001-09-04, under 510(k) number K003548.

Who is the listed applicant for PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS?

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

What is the FDA product code for PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS?

The FDA product code for PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS 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 Padpro, LLC 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.

K020743PADPRO, MODEL 2502K020203PADPRO MODEL #2516K020288PADPRO, MODEL 2603K014209PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS

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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