(196 days)
The ZOLL M Series Pulse Oximeter with Masimo SET® technology and the LNOP® Series of Sensors are indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no motion and patient motion conditions for pediatric and neonatal patients, in a hospital and pre-hospital environment.
Not Found
The provided document does not contain acceptance criteria or a study proving the device meets acceptance criteria.
The document, K982992, is primarily a Class III Summary and a 510(k) clearance letter from the FDA for a ZOLL M-Series Defibrillator SpO2 Option. It focuses on:
- Identifiying commonly reported problems for defibrillators and pacemakers (MDRs and general complaints) from advisory documents and literature searches. This is to demonstrate the manufacturer's awareness of potential issues.
- A formal FDA letter granting 510(k) clearance based on substantial equivalence to predicate devices.
- Indications for Use for the SpO2 option.
Therefore, I cannot provide the requested information. The document details problems associated with similar devices and the regulatory clearance process, but not performance criteria or a study demonstrating the specific device's performance against such criteria.
§ 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.