Product code HGN— Obstetrics/Gynecology

CONPHAR DELEE HILLIS STETHOSCOPE

Classification name
Stethoscope, Fetal
Device class
Class 1
Regulation
21 CFR 884.2900
Advisory panel
Obstetrics/Gynecology
Total cleared
2
First cleared
Most recent

Market context for product code HGN

FDA has cleared 2 devices under product code HGN between 1977 and 1981, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code HGN

Recent clearances under product code HGN

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