DeviceClearance

Product code KLK— Anesthesiology

MICROGAS 7650 TRANSCUTANEOUS MONITOR

Classification name
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device class
Class 2
Regulation
21 CFR 868.2500
Advisory panel
Anesthesiology
Total cleared
47
First cleared
Most recent

Market context for product code KLK

FDA has cleared 47 devices under product code KLK between 1978 and 2001, filed by 26 applicant companies. 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.

Clearances per year

last 15 years

Top applicants under product code KLK

Recent clearances under product code KLK

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