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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HGX | Pump, Breast, Powered | 2 | 234 | 3rd Party |
| OHH | Breast Pump Kit | 2 | 0 |