FDA 510(k)Hee HR Mini
K 號:K170269 · 2017-05-03
決定日期2017-05-03
產品代碼OHT
諮詢委員會SU
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決定相當於
器材摘要
Hee HR Mini is the device name listed in this FDA 510(k) record. The listed applicant is Oriental Inspiration Limited. It received FDA 510(k) clearance on 2017-05-03 under 510(k) number K170269. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Hee HR Mini?
Hee HR Mini is a medical device that received FDA 510(k) clearance on 2017-05-03. The listed applicant is Oriental Inspiration Limited. The 510(k) number is K170269.
When did Hee HR Mini receive FDA 510(k) clearance?
Hee HR Mini received FDA 510(k) clearance on 2017-05-03, under 510(k) number K170269.
Who is the listed applicant for Hee HR Mini?
The FDA 510(k) record lists Oriental Inspiration Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hee HR Mini?
The FDA product code for Hee HR Mini is OHT.
其他以 Oriental Inspiration Limited 為申請人之記錄
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相關器械(代碼:OHT)
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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