FDA 510(k)

ivWatch 模型 400，設備配件：擴充模組、SmartTouch 感應器、病人線材

K 號：K192385 · 2020-07-02

決定日期2020-07-02

產品代碼PMS

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable is the device name listed in this FDA 510(k) record. The listed applicant is Ivwatch, LLC. It received FDA 510(k) clearance on 2020-07-02 under 510(k) number K192385. The device is classified under product code PMS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable?

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable is a medical device that received FDA 510(k) clearance on 2020-07-02. The listed applicant is Ivwatch, LLC. The 510(k) number is K192385.

When did ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable receive FDA 510(k) clearance?

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable received FDA 510(k) clearance on 2020-07-02, under 510(k) number K192385.

Who is the listed applicant for ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable?

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

What is the FDA product code for ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable?

The FDA product code for ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable is PMS.

其他以 Ivwatch, LLC 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。

K233881ivWatch® 模型 400 K222212ivWatch 模型 400 K162478ivWatch K153605ivWatch 模型 400

相關器械（代碼：PMS）

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。

K233881ivWatch® 模型 400Ivwatch, LLC K222212ivWatch 模型 400Ivwatch, LLC K162478ivWatchIvwatch, LLC K153605ivWatch 模型 400Ivwatch, LLC

官方來源

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