FDA 510(k)

INTELLIO 平板應用程式

K 號：K192876 · 2020-02-27

決定日期2020-02-27

產品代碼ODA

諮詢委員會GU

決定相當於

器材摘要

INTELLIO Tablet Application is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew. It received FDA 510(k) clearance on 2020-02-27 under 510(k) number K192876. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the INTELLIO Tablet Application?

INTELLIO Tablet Application is a medical device that received FDA 510(k) clearance on 2020-02-27. The listed applicant is Smith & Nephew. The 510(k) number is K192876.

When did INTELLIO Tablet Application receive FDA 510(k) clearance?

INTELLIO Tablet Application received FDA 510(k) clearance on 2020-02-27, under 510(k) number K192876.

Who is the listed applicant for INTELLIO Tablet Application?

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

What is the FDA product code for INTELLIO Tablet Application?

The FDA product code for INTELLIO Tablet Application is ODA.

其他以 Smith & Nephew 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。

K241666EVOS 骨盆及骨盂系統 K240487EVOS 閃光板 K233730Footprint Mini PK, 3.5mm 緝合釘 K232457Q-FIX ULTRA 全縫線固定釘 K223762史密斯與內夫ACCORD™ 線路系統 K203566藥丸應用程序

查看所有 15 項裝置 →

相關器械（代碼：ODA）

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。

K232406KARL STORZ OR1™ SCB 控制 (WU300)Karl Storz SE & CO. KG K221929史密斯與尼普洛 INTELLIO 平板Smith+Nephew K203566藥丸應用程序Smith & Nephew K153205IDSS 力三角控制模組Black Diamond Video, Inc.K151282核心新星完整手術室內視鏡設備Richard Wolf Medical Instruments Corp.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。