PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM

• K Number: K953893
• Device Name: PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM
• Manufacturer: BIOMEDICAL SENSORS, INC.
• Date Cleared: 1997-11-04 ( 810 days)
• Product Code: CCC
• Regulation Number: 868.1150
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

Fluorescent Paratrend 7 Intravascular Monitoring System (MPM7000S)

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria, device performance, specific studies, sample sizes, ground truth establishment, or expert involvement for a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

Regulation Number and Section

§ 868.1150 Indwelling blood carbon dioxide partial pressure (P

2CO2 ) analyzer.(a)
Identification. An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”