FDA 510(k)

HVT 2.0

K 號：K221318 · 2022-12-13

決定日期2022-12-13

產品代碼QAV

諮詢委員會AN

決定相當於

器材摘要

HVT 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Vapotherm, Inc.. It received FDA 510(k) clearance on 2022-12-13 under 510(k) number K221318. The device is classified under product code QAV. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HVT 2.0?

HVT 2.0 is a medical device that received FDA 510(k) clearance on 2022-12-13. The listed applicant is Vapotherm, Inc.. The 510(k) number is K221318.

When did HVT 2.0 receive FDA 510(k) clearance?

HVT 2.0 received FDA 510(k) clearance on 2022-12-13, under 510(k) number K221318.

Who is the listed applicant for HVT 2.0?

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

What is the FDA product code for HVT 2.0?

The FDA product code for HVT 2.0 is QAV.

其他以 Vapotherm, Inc. 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。

K254078HVT 2.0 K220869Vapotherm霧化器适配器AAA-2 K203357HVT 2.0 K191010鐵鐵氏高流量治療系統

相關器械（代碼：QAV）

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。

K221338F&P空氣輔助3Fisher & Paykel Healthcare

官方來源

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