Product code KPZ— Radiology

37-701-1 PATIENT DOASE MONITOR WITH DETECTORS

Classification name
Generator, High Voltage, X-Ray, Therapeutic
Device class
Class 2
Regulation
21 CFR 892.5900
Advisory panel
Radiology
Total cleared
3
First cleared
Most recent

Market context for product code KPZ

FDA has cleared 3 devices under product code KPZ between 1986 and 1991, filed by 3 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

Top applicants under product code KPZ

Recent clearances under product code KPZ

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