FDA 510(k)

건강 전문가 전자 자극기

K-번호: K190673 · 2019-12-12

신청자Shenzhen Osto Technology Company Limited

결정일2019-12-12

제품 코드NUH

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정대체적으로 동일

기기 요약

Health Expert Electronic Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Company Limited. It received FDA 510(k) clearance on 2019-12-12 under 510(k) number K190673. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Health Expert Electronic Stimulator?

Health Expert Electronic Stimulator is a medical device that received FDA 510(k) clearance on 2019-12-12. The listed applicant is Shenzhen Osto Technology Company Limited. The 510(k) number is K190673.

When did Health Expert Electronic Stimulator receive FDA 510(k) clearance?

Health Expert Electronic Stimulator received FDA 510(k) clearance on 2019-12-12, under 510(k) number K190673.

Who is the listed applicant for Health Expert Electronic Stimulator?

The FDA 510(k) record lists Shenzhen Osto Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Health Expert Electronic Stimulator?

The FDA product code for Health Expert Electronic Stimulator is NUH.

Shenzhen Osto Technology Company Limited를 신청인으로 등재한 기타 기록

K213056LED 얼굴 마스크 K211942가열 요추 치료 패드 (모델: AST-622, AST-622B, AST-623, AST-623B)K211736전기 근육 자극기 (모델: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)K210756목 관리 치료, 모델: AST-905A, AST-905D, AST-905H K190783헬스엑스pert 전자 자극기 (모델: AST-300L)

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