FDA 510(k)

네키

K-번호: K180306 · 2018-06-08

결정일2018-06-08

제품 코드HKI

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

Nexy is the device name listed in this FDA 510(k) record. The listed applicant is Next Sight Srl. It received FDA 510(k) clearance on 2018-06-08 under 510(k) number K180306. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Nexy?

Nexy is a medical device that received FDA 510(k) clearance on 2018-06-08. The listed applicant is Next Sight Srl. The 510(k) number is K180306.

When did Nexy receive FDA 510(k) clearance?

Nexy received FDA 510(k) clearance on 2018-06-08, under 510(k) number K180306.

Who is the listed applicant for Nexy?

The FDA 510(k) record lists Next Sight Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nexy?

The FDA product code for Nexy is HKI.

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기기 요약

자주 묻는 질문

관련 기기 (코드: HKI)

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