PRO2 CHECK OXYGEN INDICATOR

• K Number: K983500
• Device Name: PRO2 CHECK OXYGEN INDICATOR
• Manufacturer: MEDICAL TECHNOLOGY SPECIALISTS, INC.
• Date Cleared: 1999-03-17 ( 162 days)
• Product Code: CCL
• Regulation Number: 868.1720
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot describe the acceptance criteria or any study details that prove the device meets those criteria.

This document is a 510(k) clearance letter from the FDA for a device called "PRO2 Check Oxygen Indicator." It states that the device is substantially equivalent to legally marketed predicate devices. However, it does not include information about specific acceptance criteria for performance, nor does it detail any studies, performance metrics, sample sizes, ground truth establishment, or expert qualifications that would be required to answer your request.

The letter focuses on regulatory approval based on substantial equivalence to existing devices, and not on presenting a detailed performance study like what would be found in a clinical trial report or a more comprehensive technical submission.

Regulation Number and Section

§ 868.1720 Oxygen gas analyzer.

(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).