FDA 510(k)

iPrime Viscodelivery System

K-번호: K212797 · 2022-01-06

결정일2022-01-06

제품 코드MRH

자문 위원회HO

결정Substantially Equivalent

기기 요약

iPrime Viscodelivery System is the device name listed in this FDA 510(k) record. The listed applicant is Glaukos. It received FDA 510(k) clearance on 2022-01-06 under 510(k) number K212797. The device is classified under product code MRH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the iPrime Viscodelivery System?

iPrime Viscodelivery System is a medical device that received FDA 510(k) clearance on 2022-01-06. The listed applicant is Glaukos. The 510(k) number is K212797.

When did iPrime Viscodelivery System receive FDA 510(k) clearance?

iPrime Viscodelivery System received FDA 510(k) clearance on 2022-01-06, under 510(k) number K212797.

Who is the listed applicant for iPrime Viscodelivery System?

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

What is the FDA product code for iPrime Viscodelivery System?

The FDA product code for iPrime Viscodelivery System is MRH.

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iPrime Viscodelivery System

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: MRH)

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