OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR

• K Number: K021442
• Device Name: OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR
• Manufacturer: OEMEDIC INTERNATIONAL, INC.
• Date Cleared: 2002-07-30 ( 85 days)
• Product Code: BTM
• Regulation Number: 868.5915
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The OEMedic International Inc. Besmed® Single Use Manual Resuscitators are indicated to temporarily augment ventilation in patients.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "Besmed® Single Use Manual Resuscitator." This document confirms that the device has been deemed substantially equivalent to a legally marketed predicate device.

However, this document does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in clinical trial reports or performance testing documentation.

Therefore, I cannot provide the requested information from this specific document. The letter focuses on regulatory approval based on substantial equivalence, not on detailed performance study results against specific acceptance criteria.

Regulation Number and Section

§ 868.5915 Manual emergency ventilator.

(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).