HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43

• K Number: K993355
• Device Name: HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
• Manufacturer: HUDSON RESPIRATORY CARE, INC.
• Date Cleared: 2000-05-24 ( 231 days)
• Product Code: BTT , FEB
• Regulation Number: 868.5450
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

When used with Hudson RCI CONCHATHERM heaters and Hudson RCI ventilator circuits, the 385-40 While Column provides heated humidification for patients with and without an artificial airway in place.

When used with the Hudson RCI CONCHATHERM heater and Cat. No. 385-40 column the 780-40, 780-41, 780-42, 780-43 circuit provides a gas conduit from the ventilator to the patient and back to the ventilator, and includes both conventional and heated wire circuit modes of neouatal ventilation.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the Hudson Respiratory Care, Inc. HRCI Cat. No. 385-40 Column and HRCI Cat. No. 780-40, 780-41, 780-42, 780-43 Circuit. This document determines substantial equivalence to legally marketed predicate devices, but does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information based on the given input.

Regulation Number and Section

§ 868.5450 Respiratory gas humidifier.

(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).