DeviceClearance

Product code MRZ— General Hospital

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM

Classification name
Accessories, Pump, Infusion
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Total cleared
48
First cleared
Most recent

Market context for product code MRZ

FDA has cleared 48 devices under product code MRZ between 1997 and 2023, filed by 29 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 MRZ

Recent clearances under product code MRZ

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