Sotair 裝置
K 號：K212905 · 2022-08-18
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器材摘要
Sotair Device is the device name listed in this FDA 510(k) record. The listed applicant is Safe Bvm Corporation. It received FDA 510(k) clearance on 2022-08-18 under 510(k) number K212905. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Sotair Device?
Sotair Device is a medical device that received FDA 510(k) clearance on 2022-08-18. The listed applicant is Safe Bvm Corporation. The 510(k) number is K212905.
When did Sotair Device receive FDA 510(k) clearance?
Sotair Device received FDA 510(k) clearance on 2022-08-18, under 510(k) number K212905.
Who is the listed applicant for Sotair Device?
The FDA 510(k) record lists Safe Bvm Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sotair Device?
The FDA product code for Sotair Device is BTM.
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相關器械（代碼：BTM）
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
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。
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