Product code HGO

Device name

Monitor, Electroencephalographic, Fetal (And Accessories)

Medical specialty

Obstetrics/Gynecology

Device class

3

Regulation number

884.2620

Review panel

OB

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96

Source

FDA openFDA device classification dataset