Uterine Electromyographic Monitor

OSP · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.2720

Classification

FDA Product Code: OSP
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 884.2720
Review panel: OB
Medical specialty: Obstetrics/Gynecology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.

Market data

Cleared 510(k) submissions: 10
Registered establishments: 10

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown