IMASK, MODELS 100, 200 AND 300

• K Number: K051559
• Device Name: IMASK, MODELS 100, 200 AND 300
• Manufacturer: VITAL SIGNS COLORADO, INC.
• Date Cleared: 2005-07-08 ( 25 days)
• Product Code: BZD
• Regulation Number: 868.5905
• Type: Special
• Panel: Anesthesiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

This device is intended to be used with positive airway pressure devices operating at or above 4cmH 2 O for the treatment of adult obstructive sleep apnea.

Device Description

iMask TM Nasal CPAP Mask

AI/ML Overview

This document is a 510(k) clearance letter for a medical device called the "iMask Nasal CPAP Mask". It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on the regulatory clearance process and confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not detail specific performance testing results or study methodologies.

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).