ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003

• K Number: K981802
• Device Name: ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003
• Manufacturer: BIO-DETEK, INC.
• Date Cleared: 1998-11-25 ( 188 days)
• Product Code: MKJ
• Regulation Number: 870.5310
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

Modified star padz Adult Multi-Function Electrodes will be used for the following clinical applications:

• Defibrillation .
• Cardioversion .
• Noninvasive Pacing .
• Electrocardingraph Monitoring ●

In conjuction with these devices:

• ZOLL PD™ 1200 Pacemaker/Defibrillator
• ZOLL PD™ 1400 Pacemaker/Defibrillator .
• ZOLL PD™ 2000 Pacemaker/Defibrillator ◆
• ZOLL D 900 Defibrillator ●
• ZOLL D 1400 Defibrillator ●
• ZOLL D 2000 Defibrillator ●
• ZOLL 1600 Pacemaker/Defibrillator
• ZOLL 1700 Pacemaker/Defibrillator .
• ZOLL NTP 1000 Noninvasive Temporary Pacemaker .
• ZOLL M Series .

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification FDA clearance letter for a medical device called "Modified stat•padz Adult Multi-Function Electrodes." It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter confirms that the FDA has found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It lists the intended uses and the types of medical personnel who will use it.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from the provided text. This type of information would typically be found in a separate study report or a detailed submission document, not in the FDA clearance letter itself.

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.