DeviceClearance

Product code NHP— Anesthesiology

INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE

Classification name
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
Device class
Class 2
Regulation
21 CFR 868.1500
Advisory panel
Anesthesiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture”

— U.S. Food and Drug Administration, device classification record for product code NHP under 21 CFR 868.1500, via openFDA

Market context for product code NHP

FDA has cleared 1 device under product code NHP, all in 2004, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NHP

Recent clearances under product code NHP

Data sourced from openFDA. This site is unofficial and independent of the FDA.