FDA 510(k)

3 시리즈 포토테라피 유닛

K-번호: K153749 · 2016-06-30

결정일2016-06-30

제품 코드FTC

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

결정대체적으로 동일

기기 요약

3 Series Phototherapy Unit 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 2016-06-30 under 510(k) number K153749. 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 3 Series Phototherapy Unit?

3 Series Phototherapy Unit is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Daavlin Distributing Company. The 510(k) number is K153749.

When did 3 Series Phototherapy Unit receive FDA 510(k) clearance?

3 Series Phototherapy Unit received FDA 510(k) clearance on 2016-06-30, under 510(k) number K153749.

Who is the listed applicant for 3 Series Phototherapy Unit?

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 3 Series Phototherapy Unit?

The FDA product code for 3 Series Phototherapy Unit is FTC.

Daavlin Distributing Company를 신청인으로 등재한 기타 기록

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