FDA 510(k)

THD 非侵入式血壓監測設備

K 號：K161785 · 2017-03-14

決定日期2017-03-14

產品代碼KLA

諮詢委員會GU

決定相當於

器材摘要

THD ANOPRESS is the device name listed in this FDA 510(k) record. The listed applicant is Thd Spa. It received FDA 510(k) clearance on 2017-03-14 under 510(k) number K161785. 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 THD ANOPRESS?

THD ANOPRESS is a medical device that received FDA 510(k) clearance on 2017-03-14. The listed applicant is Thd Spa. The 510(k) number is K161785.

When did THD ANOPRESS receive FDA 510(k) clearance?

THD ANOPRESS received FDA 510(k) clearance on 2017-03-14, under 510(k) number K161785.

Who is the listed applicant for THD ANOPRESS?

The FDA 510(k) record lists Thd Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THD ANOPRESS?

The FDA product code for THD ANOPRESS is KLA.

其他以 Thd Spa 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。

K211623THD 直腸軟體系統 K193512THD 直腸軟體系統 K180135THD Anopress 配 THD SensyProbe

相關器械（代碼：KLA）

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。

K242666Fecobionics 粪便電子系統Gi Bionics, LLC K242304紅色Neuraxis, Inc.K234107Solar™ 直腸肛門測壓導管（型號編號：K1210AC-L-2212）Laborie Medical Technologies, Corp.K180135THD Anopress 配 THD SensyProbeThd Spa

官方來源

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