FDA 510(k)

inspired™ VHB20 加熱濕化器

K 號：K222351 · 2022-12-21

決定日期2022-12-21

產品代碼BTT

諮詢委員會AN

決定相當於

器材摘要

inspired™ VHB20 Heated Humidifier is the device name listed in this FDA 510(k) record. The listed applicant is Vincent Healthcare Products Limited. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K222351. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the inspired™ VHB20 Heated Humidifier?

inspired™ VHB20 Heated Humidifier is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Vincent Healthcare Products Limited. The 510(k) number is K222351.

When did inspired™ VHB20 Heated Humidifier receive FDA 510(k) clearance?

inspired™ VHB20 Heated Humidifier received FDA 510(k) clearance on 2022-12-21, under 510(k) number K222351.

Who is the listed applicant for inspired™ VHB20 Heated Humidifier?

The FDA 510(k) record lists Vincent Healthcare Products Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for inspired™ VHB20 Heated Humidifier?

The FDA product code for inspired™ VHB20 Heated Humidifier is BTT.

其他以 Vincent Healthcare Products Limited 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。

K252066inspired™ 加熱呼吸回路 (510-008)；inspired™ 加熱呼吸回路 (510-009)；inspired™ 自動進料濕化室 (VHC10)；inspired™ 自動進料濕化室 (VHC20)

相關器械（代碼：BTT）

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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