DeviceClearance

Product code HEP— Obstetrics/Gynecology

BABYCARE

Classification name
Monitor, Blood-Flow, Ultrasonic
Device class
Class 2
Regulation
21 CFR 884.2660
Advisory panel
Obstetrics/Gynecology
Total cleared
4
First cleared
Most recent

Market context for product code HEP

FDA has cleared 4 devices under product code HEP between 1991 and 2010, filed by 4 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 HEP

Recent clearances under product code HEP

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