EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT

• K Number: K082307
• Device Name: EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT
• Manufacturer: EVENFLO COMPANY, INC.
• Date Cleared: 2008-09-11 ( 29 days)
• Product Code: HGX
• Regulation Number: 884.5160
• Type: Special
• Panel: OB
• Reference & Predicate Devices: N/A

Intended Use

The Evenflo Comfort Select Performance Breast Pump and Comfort Select Performance Dual Breast Pump are personal use battery/electric-powered suction devices used to express milk from the breast/s of lactating women.

Device Description

Not Found

AI/ML Overview

This looks like a 510(k) clearance letter for a breast pump, not a scientific study describing acceptance criteria and device performance. Therefore, I cannot extract the requested information like sample size, ground truth, expert qualifications, or details about a comparative effectiveness study.

The document states that the Evenflo Comfort Select Performance Breast Pump and Dual Breast Pump are for "personal use battery/electric-powered suction devices used to express milk from the breast/s of lactating women." It grants clearance based on substantial equivalence to a predicate device, not on meeting specific, detailed performance criteria from a clinical study described within 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).