HGO — Monitor, Electroencephalographic, Fetal (And Accessories) Class III

FDA Device Classification

FDA product code HGO covers "Monitor, Electroencephalographic, Fetal (And Accessories)", a Class III medical device regulated under 21 CFR 884.2620. Submissions are reviewed by the Obstetrics/Gynecology panel.

Classification Details

Product Code
HGO
Device Class
Class III
Regulation Number
884.2620
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Definition

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