Product code FRQ— Gastroenterology, Urology

ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT

Classification name
Tube, Levine
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Total cleared
3
First cleared
Most recent

Market context for product code FRQ

FDA has cleared 3 devices under product code FRQ between 1980 and 1992, 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 FRQ

Recent clearances under product code FRQ

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