21 CFR 884.5160 — Pump, Breast, Powered

Obstetrics/Gynecology (OB) · Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices · § 884.5160

Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HGXPump, Breast, Powered22343rd Party
OHHBreast Pump Kit20
Innolitics

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