FDA 510(k)

마스터X 800 시리즈

K-번호: K230918 · 2023-09-01

결정일2023-09-01

제품 코드MQB

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

결정대체적으로 동일

기기 요약

MasterX 800 Series is the device name listed in this FDA 510(k) record. The listed applicant is Medicatech USA. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K230918. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the MasterX 800 Series?

MasterX 800 Series is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Medicatech USA. The 510(k) number is K230918.

When did MasterX 800 Series receive FDA 510(k) clearance?

MasterX 800 Series received FDA 510(k) clearance on 2023-09-01, under 510(k) number K230918.

Who is the listed applicant for MasterX 800 Series?

The FDA 510(k) record lists Medicatech USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MasterX 800 Series?

The FDA product code for MasterX 800 Series is MQB.

Medicatech USA를 신청인으로 등재한 기타 기록

K190601마스터라드 MX30

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