APEX MEDICAL CPAP MODEL 9S-003

• K Number: K041828
• Device Name: APEX MEDICAL CPAP MODEL 9S-003
• Manufacturer: APEX MEDICAL CORP.
• Date Cleared: 2004-07-30 ( 23 days)
• Product Code: BZD
• Regulation Number: 868.5905
• Type: Special
• Panel: AN
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA).

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a CPAP device. It does not contain information about the acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications that would be needed to answer your request.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..." This type of clearance relies on demonstrating substantial equivalence to an existing device, rather than providing independent clinical study data to prove specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot provide the requested table and study details based on the information given.

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).