FDA 510(k)

Solar™ 肛门直肠测压导管（型号：K1210AC-L-2212）

K号: K234107 · 2024-04-23

决定日期2024-04-23

产品代码KLA

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决定实质等同

器械摘要

Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) is the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Technologies, Corp.. It received FDA 510(k) clearance on 2024-04-23 under 510(k) number K234107. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)?

Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) is a medical device that received FDA 510(k) clearance on 2024-04-23. The listed applicant is Laborie Medical Technologies, Corp.. The 510(k) number is K234107.

When did Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) receive FDA 510(k) clearance?

Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) received FDA 510(k) clearance on 2024-04-23, under 510(k) number K234107.

Who is the listed applicant for Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)?

The FDA 510(k) record lists Laborie Medical Technologies, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)?

The FDA product code for Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) is KLA.

列明Laborie Medical Technologies, Corp.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。

K241523injeTAK可调尖针（DIS199；DIS201）K240007Solar Compact (G4-1)

官方来源

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