FDA 510(k)

Cosmed Q-NRG / Q-NRG+ 隨身代謝監測器

K 號：K190800 · 2020-02-06

決定日期2020-02-06

產品代碼BTY

諮詢委員會AN

決定相當於

器材摘要

Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors is the device name listed in this FDA 510(k) record. The listed applicant is Cosmed Srl. It received FDA 510(k) clearance on 2020-02-06 under 510(k) number K190800. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors?

Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors is a medical device that received FDA 510(k) clearance on 2020-02-06. The listed applicant is Cosmed Srl. The 510(k) number is K190800.

When did Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors receive FDA 510(k) clearance?

Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors received FDA 510(k) clearance on 2020-02-06, under 510(k) number K190800.

Who is the listed applicant for Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors?

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 Q-NRG / Q-NRG+ Portable Metabolic Monitors?

The FDA product code for Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors is BTY.

其他以 Cosmed Srl 為申請人之記錄

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相關器械（代碼：BTY）

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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官方來源

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