DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400

• K Number: K070435
• Device Name: DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400
• Manufacturer: WHITTLESTONE, INC.
• Date Cleared: 2007-07-17 ( 152 days)
• Product Code: HGX
• Regulation Number: 884.5160
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Powered Breast Pump used to express milk from lactating women

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA for a breast pump, "Dr. Brown's Natural Flow Double Electric Breast Pump." It confirms the device's substantial equivalence to a legally marketed predicate device.

This document does not contain information regarding the acceptance criteria for performance, details of a study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types or establishment for training/test sets). It is a regulatory approval letter based on substantial equivalence, not a medical device performance study report.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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).