FDA 510(k)

3400E 시리즈; E5400 시리즈; E6400 시리즈; Sundazzler 시리즈

K-번호: K151905 · 2016-03-01

결정일2016-03-01

제품 코드LEJ

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

결정대체적으로 동일

기기 요약

3400E series; E5400 series; E6400 series; Sundazzler series is the device name listed in this FDA 510(k) record. The listed applicant is Heartland Tanning, Inc.. It received FDA 510(k) clearance on 2016-03-01 under 510(k) number K151905. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the 3400E series; E5400 series; E6400 series; Sundazzler series?

3400E series; E5400 series; E6400 series; Sundazzler series is a medical device that received FDA 510(k) clearance on 2016-03-01. The listed applicant is Heartland Tanning, Inc.. The 510(k) number is K151905.

When did 3400E series; E5400 series; E6400 series; Sundazzler series receive FDA 510(k) clearance?

3400E series; E5400 series; E6400 series; Sundazzler series received FDA 510(k) clearance on 2016-03-01, under 510(k) number K151905.

Who is the listed applicant for 3400E series; E5400 series; E6400 series; Sundazzler series?

The FDA 510(k) record lists Heartland Tanning, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3400E series; E5400 series; E6400 series; Sundazzler series?

The FDA product code for 3400E series; E5400 series; E6400 series; Sundazzler series is LEJ.

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3400E 시리즈; E5400 시리즈; E6400 시리즈; Sundazzler 시리즈

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LEJ)

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