DeviceClearance

Product code KZM— Physical Medicine

BIO-EMG MODEL 800

Classification name
Device, Muscle Monitoring
Device class
Class 2
Regulation
21 CFR 890.1375
Advisory panel
Physical Medicine
Total cleared
19
First cleared
Most recent

Market context for product code KZM

FDA has cleared 19 devices under product code KZM between 1981 and 2016, filed by 11 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 KZM

Recent clearances under product code KZM

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