ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE

• K Number: K093525
• Device Name: ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE
• Manufacturer: VENTLAB CORP.
• Date Cleared: 2009-12-10 ( 24 days)
• Product Code: CCK
• Regulation Number: 868.1400
• Type: Special
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

The ACE/StatCheck II is intended for use as an adjunct assessment tool for verification of successful ventilation/intubation in patients >2.2 kilograms(51bs.).

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the ACE/StatCheck II CO2 Indicator. It does not contain the specific information requested about acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations.

Therefore, I cannot extract the requested information from the provided text.

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).