FDA 510(k)

VibrantVue Scleral Saline

K-번호: K201069 · 2020-07-31

결정일2020-07-31

제품 코드MRC

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

VibrantVue Scleral Saline is the device name listed in this FDA 510(k) record. The listed applicant is Dry Eye Innovations, LLC. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K201069. The device is classified under product code MRC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the VibrantVue Scleral Saline?

VibrantVue Scleral Saline is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Dry Eye Innovations, LLC. The 510(k) number is K201069.

When did VibrantVue Scleral Saline receive FDA 510(k) clearance?

VibrantVue Scleral Saline received FDA 510(k) clearance on 2020-07-31, under 510(k) number K201069.

Who is the listed applicant for VibrantVue Scleral Saline?

The FDA 510(k) record lists Dry Eye Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VibrantVue Scleral Saline?

The FDA product code for VibrantVue Scleral Saline is MRC.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

VibrantVue Scleral Saline

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: MRC)

공식 출처