FDA 510(k)

rainbow MCT

K-번호: K200270 · 2021-04-16

결정일2021-04-16

제품 코드OAS

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

결정대체적으로 동일

기기 요약

rainbow MCT is the device name listed in this FDA 510(k) record. The listed applicant is Dentium Co., Ltd (Ict Branch). It received FDA 510(k) clearance on 2021-04-16 under 510(k) number K200270. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the rainbow MCT?

rainbow MCT is a medical device that received FDA 510(k) clearance on 2021-04-16. The listed applicant is Dentium Co., Ltd (Ict Branch). The 510(k) number is K200270.

When did rainbow MCT receive FDA 510(k) clearance?

rainbow MCT received FDA 510(k) clearance on 2021-04-16, under 510(k) number K200270.

Who is the listed applicant for rainbow MCT?

The FDA 510(k) record lists Dentium Co., Ltd (Ict Branch) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for rainbow MCT?

The FDA product code for rainbow MCT is OAS.

Dentium Co., Ltd (Ict Branch)를 신청인으로 등재한 기타 기록

K231181bright CT K200271rainbow CT K201247구강 내 센서

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