FDA 510(k)

COSMED K5 穿著式代謝技術

K 號：K162515 · 2017-06-20

決定日期2017-06-20

產品代碼BZC

諮詢委員會AN

決定相當於

器材摘要

COSMED K5 Wearable Metabolic Technology is the device name listed in this FDA 510(k) record. The listed applicant is Cosmed Srl. It received FDA 510(k) clearance on 2017-06-20 under 510(k) number K162515. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the COSMED K5 Wearable Metabolic Technology?

COSMED K5 Wearable Metabolic Technology is a medical device that received FDA 510(k) clearance on 2017-06-20. The listed applicant is Cosmed Srl. The 510(k) number is K162515.

When did COSMED K5 Wearable Metabolic Technology receive FDA 510(k) clearance?

COSMED K5 Wearable Metabolic Technology received FDA 510(k) clearance on 2017-06-20, under 510(k) number K162515.

Who is the listed applicant for COSMED K5 Wearable Metabolic Technology?

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

What is the FDA product code for COSMED K5 Wearable Metabolic Technology?

The FDA product code for COSMED K5 Wearable Metabolic Technology is BZC.

其他以 Cosmed Srl 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。

K190800Cosmed Q-NRG / Q-NRG+ 隨身代謝監測器

相關器械（代碼：BZC）

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。

K240293STS 請注意，這裡的 "STS" 似乎是一個設備名稱或識別碼，並未提供完整的文檔內容，因此無法進行完整的翻譯。如果您能提供完整的文檔內容，我將能夠提供正確的翻譯。Techbopulm, Ltd.K183567維恩圖斯/哨兵套件產品線Vyaire Medical K190853維恩塔斯BODYVyaire Medical, Inc.K181524Vyntus ONE 配 CART，Vyntus ONE PFT 只配 CART，Vyntus ONE 配可調節 CART，Vyntus ONE PFT 只配可調節 CARTVyaire Medical, Inc.K161295MiniBox +Pulmone Advanced Medical Devices, Ltd.

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。