ZOLL M SERIES ETCO2 OPTION

• K Number: K993036
• Device Name: ZOLL M SERIES ETCO2 OPTION
• Manufacturer: ZOLL MEDICAL CORP.
• Date Cleared: 2000-02-28 ( 172 days)
• Product Code: MKJ , DAT
• Regulation Number: 870.5310
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The ZOLL M Series EtCO2 option with Novametrix technology and Capnostal® sensor is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, transport, and anesthesia.

Device Description

ZOLL M Series EtCO2 Option

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the ZOLL M Series EtCO2 Option. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information based on the provided text.

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.