FDA 510(k)

PROBEAT-V 및 액세서리

K-번호: K153614 · 2016-04-21

결정일2016-04-21

제품 코드LHN

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

결정대체적으로 동일

기기 요약

PROBEAT-V and accessories is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi, Ltd., Health Care Company. It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K153614. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PROBEAT-V and accessories?

PROBEAT-V and accessories is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Hitachi, Ltd., Health Care Company. The 510(k) number is K153614.

When did PROBEAT-V and accessories receive FDA 510(k) clearance?

PROBEAT-V and accessories received FDA 510(k) clearance on 2016-04-21, under 510(k) number K153614.

Who is the listed applicant for PROBEAT-V and accessories?

The FDA 510(k) record lists Hitachi, Ltd., Health Care Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROBEAT-V and accessories?

The FDA product code for PROBEAT-V and accessories is LHN.

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PROBEAT-V 및 액세서리

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LHN)

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