NICCHECK I

• K Number: K963733
• Device Name: NICCHECK I
• Manufacturer: DYNAGEN, INC.
• Date Cleared: 1996-12-13 ( 88 days)
• Product Code: MRS
• Regulation Number: 862.3220
• Type: Traditional
• Panel: Toxicology
• Reference & Predicate Devices: N/A
• Predicate For: K192299

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Summary

Loading...

Regulation Number and Section

§ 862.3220 Carbon monoxide test system.

(a)
Identification. A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.