QARA MDR CE MARKING February 12, 2021

The sampling criteria: The main sampling criteria are lot sizes, inspection levels, acceptable qua...

QARA FDA 510k February 9, 2021

...

QARA FDA 510k January 31, 2021

...

QARA Resources, FDA 510k July 31, 2020

...

QARA FDA 510k July 30, 2020

Substantial Equivalence is the demonstration that a new device, compared to a predicate device for t...

QARA FDA 510k June 25, 2020

Abbreviated 510 k The medical devices for which the 510 k or premarket notification is requir...

QARA FDA 510k June 25, 2020

510 k Summary or Statement 510 k Summary or Statement is part of the 510 k file of a medical ...

QARA FDA 510k June 24, 2020

Traditional 510 k The Traditional 510 k is one among the three types of the 510 k in the US F...