POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER

• K Number: K982127
• Device Name: POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
• Manufacturer: POROUS MEDIA CORP.
• Date Cleared: 1998-06-23 ( 6 days)
• Product Code: CAH
• Regulation Number: 868.5260
• Type: Special
• Panel: HO
• Reference & Predicate Devices: K964979

Intended Use

THIS DISPOSABLE FILTER HAS BEEN DESIGNED FOR SINGLE USE AS A MAIN FLOW FILTER, INSPIRATORY AND EXHALATION FILTER. THIS FILTER IS HYDROPHOBIC. FOR USE WITH RESPIRATORY THERAPY AND ANESTHESIA APPLICATIONS. HELPS PROTECT PATIENTS FROM RESPIRATORY AND ANESTHESIA VENTILATOR CONTAMINANTS. VERSATILE, DISPOSABLE, ENCONOMY OF USE - HELPS PROTECT PATIENT, VENTILATORY EQUIPMENT, AND HOSPITAL STAFF.

Device Description

One Disposable Breathing Circuit Bacterial Filter. CLEAR PLASTIC SHELL ALLOWS FOR VISUAL INSPECTION OF THE FILTER MEDIUM.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a respiratory filter and does not discuss acceptance criteria, device performance studies, or details about training and test sets as typically seen in AI/ML device submissions.

Regulation Number and Section

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).