NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068

• K Number: K033131
• Device Name: NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068
• Manufacturer: THE FIRST YEARS, INC.
• Date Cleared: 2003-10-30 ( 30 days)
• Product Code: HGX
• Regulation Number: 884.5160
• Type: Special
• Panel: OB
• Reference & Predicate Devices: N/A

Intended Use

Powered Breast Pump to express milk from the breast.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA for a breast pump. It does not contain information about acceptance criteria or a study proving device performance as requested. The content focuses on the regulatory clearance for the device, including its classification and compliance requirements. Therefore, I cannot provide the requested information based on this document.

Regulation Number and Section

§ 884.5160 Powered breast pump.

(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).