FDA 510(k)

클리어링크 제어형 조명치료 장비

K-번호: K182215 · 2018-10-29

결정일2018-10-29

제품 코드FTC

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

결정대체적으로 동일

기기 요약

ClearLink Controlled Phototherapy Equipment is the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Distributing Company. It received FDA 510(k) clearance on 2018-10-29 under 510(k) number K182215. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ClearLink Controlled Phototherapy Equipment?

ClearLink Controlled Phototherapy Equipment is a medical device that received FDA 510(k) clearance on 2018-10-29. The listed applicant is Daavlin Distributing Company. The 510(k) number is K182215.

When did ClearLink Controlled Phototherapy Equipment receive FDA 510(k) clearance?

ClearLink Controlled Phototherapy Equipment received FDA 510(k) clearance on 2018-10-29, under 510(k) number K182215.

Who is the listed applicant for ClearLink Controlled Phototherapy Equipment?

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

What is the FDA product code for ClearLink Controlled Phototherapy Equipment?

The FDA product code for ClearLink Controlled Phototherapy Equipment is FTC.

Daavlin Distributing Company를 신청인으로 등재한 기타 기록

K1537493 시리즈 포토테라피 유닛

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