SIMPLE T YOUTH NASAL MASK

• K Number: K140268
• Device Name: SIMPLE T YOUTH NASAL MASK
• Manufacturer: RESPIRONICS, INC.
• Date Cleared: 2014-10-20 ( 250 days)
• Product Code: BZD
• Regulation Number: 868.5905
• Type: Abbreviated
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

The Simple T Youth Nasal Mask is intended for use with CPAP or bi-level therapy.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the U.S. FDA document is heavily corrupted and contains significant amounts of non-English and garbled characters, particularly in the sections that would typically detail acceptance criteria and study information.

Due to the severe corruption, I cannot extract the specific information requested regarding the acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth methods.

The document appears to be a 510(k) clearance letter for the "Simple T Youth Nasal Mask," but the technical details about its performance studies are unreadable in the provided segments.

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).