FDA 510(k)

LUMIX CPS 1 이온 램프 시스템 LUMIX CPS 2 이온 램프 시스템 LUMIX CPS 3 이온 램프 시스템 LUMIX CPS 4 이온 램프 시스템 LUMIX CPS 5 이온 램프 시스템

K-번호: K160947 · 2016-07-05

결정일2016-07-05

제품 코드ILY

자문 위원회의료장비 규제 텍스트 번역 PM [회사명/제품명]은 FDA(미국 식품의약국)에 등록된 의료장비로, 510(k) 신청을 통해 시장에 출시되었습니다. PMA(Premarket Approval) 신청도 진행 중입니다. 연구 참가자를 모으기 위해 NCT(National Clinical Trial) 번호 [NCT]와 PMID(Publication Medical Identifier) [PMID]를 사용하고 있습니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL] 정책: medical-regulatory-v1

결정대체적으로 동일

기기 요약

LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System is the device name listed in this FDA 510(k) record. The listed applicant is Usa Laser Biotech, Inc.. It received FDA 510(k) clearance on 2016-07-05 under 510(k) number K160947. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System?

LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System is a medical device that received FDA 510(k) clearance on 2016-07-05. The listed applicant is Usa Laser Biotech, Inc.. The 510(k) number is K160947.

When did LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System receive FDA 510(k) clearance?

LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System received FDA 510(k) clearance on 2016-07-05, under 510(k) number K160947.

Who is the listed applicant for LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System?

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

What is the FDA product code for LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System?

The FDA product code for LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System is ILY.

Usa Laser Biotech, Inc.를 신청인으로 등재한 기타 기록

K161198룸릭스 울트라 1, 룸릭스 울트라 2, 룸릭스 울트라 3

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