FDA 510(k)

BH 메디칼 데ンタル 바리어 슬리브 및 바리어 필름

K-번호: K190484 · 2019-09-10

결정일2019-09-10

제품 코드PEM

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

결정대체적으로 동일

기기 요약

BH Medical Dental Barrier Sleeves and Barrier Film is the device name listed in this FDA 510(k) record. The listed applicant is Bh Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2019-09-10 under 510(k) number K190484. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the BH Medical Dental Barrier Sleeves and Barrier Film?

BH Medical Dental Barrier Sleeves and Barrier Film is a medical device that received FDA 510(k) clearance on 2019-09-10. The listed applicant is Bh Medical Products Co., Ltd.. The 510(k) number is K190484.

When did BH Medical Dental Barrier Sleeves and Barrier Film receive FDA 510(k) clearance?

BH Medical Dental Barrier Sleeves and Barrier Film received FDA 510(k) clearance on 2019-09-10, under 510(k) number K190484.

Who is the listed applicant for BH Medical Dental Barrier Sleeves and Barrier Film?

The FDA 510(k) record lists Bh Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BH Medical Dental Barrier Sleeves and Barrier Film?

The FDA product code for BH Medical Dental Barrier Sleeves and Barrier Film is PEM.

Bh Medical Products Co., Ltd.를 신청인으로 등재한 기타 기록

K172280BH 소독 푸치

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