ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER

• K Number: K024023
• Device Name: ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER
• Manufacturer: ESSEX MEDICAL SYSTEMS PLUS
• Date Cleared: 2003-10-01 ( 300 days)
• Product Code: NFB
• Regulation Number: 868.5905
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

The Essex High Pressure (HP) OCD and Essex Escort Pneumatic Conserver are used to deliver a prescribed flow of gas to the patient while conserving gas, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.

Device Description

Not Found

AI/ML Overview

This document is a marketing authorization letter for the "Essex High Pressure (HP) OCD and Essex Escort Pneumatic Conserver" (K024023) and does not contain information about acceptance criteria or a study proving that a device meets those criteria. The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

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

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).