Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)

• K Number: K233913
• Device Name: Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)
• Manufacturer: AOJ Health Technology Co., Ltd.
• Date Cleared: 2024-05-14 ( 154 days)
• Product Code: HGX
• Regulation Number: 884.5160
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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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).