FDA 510(k)

Solar™ 直腸肛門測壓導管（型號編號：K1210AC-L-2212）

K 號：K234107 · 2024-04-23

決定日期2024-04-23

產品代碼KLA

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Laborie Medical Technologies, Corp. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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