DeviceClearance

Product code IKE— Physical Medicine

ASC 4080 SYSTEM

Classification name
Transducer, Miniature Pressure
Device class
Class 1
Regulation
21 CFR 890.1615
Advisory panel
Physical Medicine
Total cleared
15
First cleared
Most recent

Market context for product code IKE

FDA has cleared 15 devices under product code IKE between 1984 and 2006, filed by 14 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code IKE

Recent clearances under product code IKE

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