DeviceClearance

Product code DRQ— Cardiovascular

ACIST RXi Mini System

Classification name
Amplifier And Signal Conditioner, Transducer Signal
Device class
Class 2
Regulation
21 CFR 870.2060
Advisory panel
Cardiovascular
Total cleared
27
First cleared
Most recent

Market context for product code DRQ

FDA has cleared 27 devices under product code DRQ between 1976 and 2017, filed by 22 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 DRQ

Recent clearances under product code DRQ

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