DeviceClearance

Product code FLK— General Hospital

AMG MED BRAND CLINICAL GLASS THERMOMETER

Classification name
Thermometer, Clinical Mercury
Device class
Class 2
Regulation
21 CFR 880.2920
Advisory panel
General Hospital
Total cleared
33
First cleared
Most recent

Market context for product code FLK

FDA has cleared 33 devices under product code FLK between 1976 and 1996, filed by 31 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 FLK

Recent clearances under product code FLK

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