FDA 510(k)

Boston One Step Liquid Enzymatic Cleaner

K-번호: K200416 · 2020-09-23

결정일2020-09-23

제품 코드MRC

자문 위원회OP

결정Substantially Equivalent

기기 요약

Boston One Step Liquid Enzymatic Cleaner is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2020-09-23 under 510(k) number K200416. 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 Boston One Step Liquid Enzymatic Cleaner?

Boston One Step Liquid Enzymatic Cleaner is a medical device that received FDA 510(k) clearance on 2020-09-23. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K200416.

When did Boston One Step Liquid Enzymatic Cleaner receive FDA 510(k) clearance?

Boston One Step Liquid Enzymatic Cleaner received FDA 510(k) clearance on 2020-09-23, under 510(k) number K200416.

Who is the listed applicant for Boston One Step Liquid Enzymatic Cleaner?

The FDA 510(k) record lists Bausch & Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Boston One Step Liquid Enzymatic Cleaner?

The FDA product code for Boston One Step Liquid Enzymatic Cleaner is MRC.

Bausch & Lomb, Incorporated를 신청인으로 등재한 기타 기록

K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)K242389EyeGility™ Inserter for Preloaded enVista IOLs K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)K220613Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia K222541Bausch + Lomb Preservative Free Lubricating and Rewetting Drops K202932ABT12 다용도 솔루션

17개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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