Desara TV, Desara 藍色電視
K 號：K162201 · 2017-01-11
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器材摘要
Desara TV, Desara Blue TV is the device name listed in this FDA 510(k) record. The listed applicant is Caldera Medical, Inc.. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K162201. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Desara TV, Desara Blue TV?
Desara TV, Desara Blue TV is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K162201.
When did Desara TV, Desara Blue TV receive FDA 510(k) clearance?
Desara TV, Desara Blue TV received FDA 510(k) clearance on 2017-01-11, under 510(k) number K162201.
Who is the listed applicant for Desara TV, Desara Blue TV?
The FDA 510(k) record lists Caldera Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Desara TV, Desara Blue TV?
The FDA product code for Desara TV, Desara Blue TV is OTN.
相關臨床試驗
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其他以 Caldera Medical, 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。
相關器械（代碼：OTN）
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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