SML-OSA2 製備
K 號：K162816 · 2017-07-27
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器材摘要
SML-OSA2 Appliances is the device name listed in this FDA 510(k) record. The listed applicant is Selane Products, Inc.. It received FDA 510(k) clearance on 2017-07-27 under 510(k) number K162816. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SML-OSA2 Appliances?
SML-OSA2 Appliances is a medical device that received FDA 510(k) clearance on 2017-07-27. The listed applicant is Selane Products, Inc.. The 510(k) number is K162816.
When did SML-OSA2 Appliances receive FDA 510(k) clearance?
SML-OSA2 Appliances received FDA 510(k) clearance on 2017-07-27, under 510(k) number K162816.
Who is the listed applicant for SML-OSA2 Appliances?
The FDA 510(k) record lists Selane Products, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SML-OSA2 Appliances?
The FDA product code for SML-OSA2 Appliances is LQZ.
相關臨床試驗
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相關器械（代碼：LQZ）
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。
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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