FDA 510(k)

xPORT 304（miCOR）系统镜头碎片化系统

K号: K200584 · 2020-07-31

申请人Carl Zeiss Meditec Cataract Technology, Inc.

决定日期2020-07-31

产品代码HQC

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决定实质等同

器械摘要

xPORT 304 (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 2020-07-31 under 510(k) number K200584. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the xPORT 304 (miCOR) System Lens Fragmentation System?

xPORT 304 (miCOR) System Lens Fragmentation System is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Carl Zeiss Meditec Cataract Technology, Inc.. The 510(k) number is K200584.

When did xPORT 304 (miCOR) System Lens Fragmentation System receive FDA 510(k) clearance?

xPORT 304 (miCOR) System Lens Fragmentation System received FDA 510(k) clearance on 2020-07-31, under 510(k) number K200584.

Who is the listed applicant for xPORT 304 (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 xPORT 304 (miCOR) System Lens Fragmentation System?

The FDA product code for xPORT 304 (miCOR) System Lens Fragmentation System is HQC.

列明Carl Zeiss Meditec Cataract Technology, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K243395MICOR 700 自动 I/A K242801MICOR 700 系统 (N/A)；MICOR 700 驱动器 (FG-50631)；MICOR 700 提取器 (FG-50621)；MICOR 700 视网膜剪刀 (FG-51185)K214028MICOR 镜片破碎系统 K222236miCOR系统镜头碎片化系统 K200207xPORT S 镜片破碎系统 K191024xPORT 镜片碎片化系统

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相关器械（代码：HQC）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261264Stellaris Elite™视觉增强系统；后部和联合手术包：23号后部Elite™包(SE5423)；23号双刀片™玻璃体切割器后部Stellaris Elite™包(SE5423B)；25号后部Elite™包(SE5425)；25号双刀片™玻璃体切割器后部Stellaris Elite™包(SE5425B)；27号双刀片™玻璃体切割器后部Stellaris Elite™包(SE5427B)；23号双刀片™+玻璃体切割器后部Stellaris Elite™包(SE5423BB+)Bausch and Lomb K252052Stellaris Elite™视觉增强系统(BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, Incorporated K250501System SophiThis AG K243395MICOR 700 自动 I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 系统 (N/A)；MICOR 700 驱动器 (FG-50631)；MICOR 700 提取器 (FG-50621)；MICOR 700 视网膜剪刀 (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite视觉增强系统(BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

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