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K Number
K946127
Device Name
OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM
Manufacturer
OHMEDA MEDICAL
Date Cleared
1996-10-08

(663 days)

Product Code
BSZ
Regulation Number
868.5160
Type
Traditional
Panel
Anesthesiology
Reference & Predicate Devices
K863207
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Ohmeda Excel Draw-Over Military Vaporizer System is specifically designed for use with the Ohmeda Single-Agent Draw-Over Vaporizer. It consists of an Excel 210 system with an attached draw-over vaporizer. The purpose is to provide a platform for the delivery of inhalation anesthetic agents using the draw-over vaporizer and supplemental gas supply.

Device Description

The Ohmeda Excel Draw-Over Military Vaporizer System is a modification of the Ohmeda Excel 210 that has been made to facilitate the Ohmeda Single-Agent Draw-Over Vaporizer and the militaries needs. The system consists of an Ohmeda Single Agent Draw Over Vaporizer and a kit that allows the vaporizer to be used with an Ohmeda Excel system. The kit consists of mounting attachments, O2 flush cover, monitoring ports, scavenging interconnection, and an extended length oxygen enrichment tube.

AI/ML Overview

This document is a 510(k) summary for the Ohmeda Excel Draw-Over Military Vaporizer System, seeking to establish substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document focuses on regulatory classification, substantial equivalence arguments, and design modifications of the device.

Therefore, I cannot provide the requested information.

§ 868.5160 Gas machine for anesthesia or analgesia.

(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).