FDA 510(k)

Aimanfun Lumea Comfort

K-번호: K190820 · 2019-10-02

결정일2019-10-02

제품 코드OHT

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정Substantially Equivalent

기기 요약

Aimanfun Lumea Comfort is the device name listed in this FDA 510(k) record. The listed applicant is Kam Yuen Plastic Products , Ltd.. It received FDA 510(k) clearance on 2019-10-02 under 510(k) number K190820. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Aimanfun Lumea Comfort?

Aimanfun Lumea Comfort is a medical device that received FDA 510(k) clearance on 2019-10-02. The listed applicant is Kam Yuen Plastic Products , Ltd.. The 510(k) number is K190820.

When did Aimanfun Lumea Comfort receive FDA 510(k) clearance?

Aimanfun Lumea Comfort received FDA 510(k) clearance on 2019-10-02, under 510(k) number K190820.

Who is the listed applicant for Aimanfun Lumea Comfort?

The FDA 510(k) record lists Kam Yuen Plastic Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aimanfun Lumea Comfort?

The FDA product code for Aimanfun Lumea Comfort is OHT.

Kam Yuen Plastic Products , Ltd.를 신청인으로 등재한 기타 기록

K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)K230107Aimanfun Lumea Comfort, 모델: A-2788, A-2789 및 A-3588 K213027레이저 헤어 성장 커브 K213025레이저 털 자라는 헬멧 K212907Aimanfun Lumea Comfort, A-2789/A-3588

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