Product code HEJ

Device name

Monitor, Hemic Sound, Ultrasonic

Medical specialty

Obstetrics/Gynecology

Device class

2

Regulation number

884.2660

Review panel

OB

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

Source

FDA openFDA device classification dataset