FDA 510(k)

miCOR System Lens Fragmentation System

K-번호: K222236 · 2022-08-24

신청자Carl Zeiss Meditec Cataract Technology, Inc.

결정일2022-08-24

제품 코드HQC

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

miCOR System Lens Fragmentation System is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec Cataract Technology, Inc.. It received FDA 510(k) clearance on 2022-08-24 under 510(k) number K222236. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the miCOR System Lens Fragmentation System?

miCOR System Lens Fragmentation System is a medical device that received FDA 510(k) clearance on 2022-08-24. The listed applicant is Carl Zeiss Meditec Cataract Technology, Inc.. The 510(k) number is K222236.

When did miCOR System Lens Fragmentation System receive FDA 510(k) clearance?

miCOR System Lens Fragmentation System received FDA 510(k) clearance on 2022-08-24, under 510(k) number K222236.

Who is the listed applicant for miCOR System Lens Fragmentation System?

The FDA 510(k) record lists Carl Zeiss Meditec Cataract Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for miCOR System Lens Fragmentation System?

The FDA product code for miCOR System Lens Fragmentation System is HQC.

Carl Zeiss Meditec Cataract Technology, Inc.를 신청인으로 등재한 기타 기록

K243395MICOR 700 자동 I/A와 함께 K242801MICOR 700 시스템 (N/A); MICOR 700 드라이브 (FG-50631); MICOR 700 추출기 (FG-50621); MICOR 700 비트렉터 (FG-51185)K214028미코어 렌즈 파편화 시스템 K200207xPORT S Lens Fragmentation System K200584xPORT 304 (miCOR) System Lens Fragmentation System K191024xPORT Lens Fragmentation System

7개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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