21 CFR 884.2685 — Electrode, Clip, Fetal Scalp (And Applicator)

Obstetrics/Gynecology (OB) · Part 884 Subpart C—Obstetrical and Gynecological Monitoring Devices · § 884.2685

Identification

A fetal scalp clip electrode and applicator is a device designed to establish electrical contact between fetal skin and an external monitoring device by means of pinching skin tissue with a nonreusable clip. This device is used to obtain a fetal electrocardiogram. This generic type of device may include a clip electrode applicator.

Classification Rationale

Class III (premarket approval).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HIQElectrode, Clip, Fetal Scalp (And Applicator)30
Innolitics

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