MALLARD MODEL 3000 ANESTHESIA MACHINE by MALLARD MEDICAL, INC. | FDA 510(k) Summary

FDA 510(k) Search

K Number

Device Name

MALLARD MODEL 3000 ANESTHESIA MACHINE

Manufacturer

MALLARD MEDICAL, INC.

Date Cleared

2004-09-03

(343 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

For the delivery of inhalation anesthesia gases in a medical setting.

Device Description

Not Found

AI/ML Overview

The provided text pertains to an FDA 510(k) clearance letter for the Mallard Model 3000 Anesthesia Machine. This document is a regulatory approval and does not contain information about a study proving the device meets acceptance criteria, an AI algorithm, or any of the detailed performance metrics requested in your prompt.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study design, expert qualifications, or ground truth establishment from this document. The document primarily focuses on the device's regulatory classification, its substantial equivalence to a predicate device, and the indications for use.

Summary

Regulation Number and Section

§ 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).