COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR

• K Number: K970769
• Device Name: COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR
• Manufacturer: ARISTO MEDICAL
• Date Cleared: 1997-08-28 ( 178 days)
• Product Code: DQA
• Regulation Number: 870.2700
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

Continuous or spot monitoring of non-invasive arterial oxygen saturation.

Device Description

ComSat Oximeter Sensors / ComSat Pulse Oximeter Probes

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA concerning the substantial equivalence of the ComSat Oximeter Sensors to a legally marketed predicate device. It does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).