逆向調節式拉開式口罩
K 號：K162543 · 2017-08-28
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器材摘要
Reverse Pull Adjustable Facemask is the device name listed in this FDA 510(k) record. The listed applicant is Sawbros Industries Pvt., Ltd.. It received FDA 510(k) clearance on 2017-08-28 under 510(k) number K162543. The device is classified under product code DZB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Reverse Pull Adjustable Facemask?
Reverse Pull Adjustable Facemask is a medical device that received FDA 510(k) clearance on 2017-08-28. The listed applicant is Sawbros Industries Pvt., Ltd.. The 510(k) number is K162543.
When did Reverse Pull Adjustable Facemask receive FDA 510(k) clearance?
Reverse Pull Adjustable Facemask received FDA 510(k) clearance on 2017-08-28, under 510(k) number K162543.
Who is the listed applicant for Reverse Pull Adjustable Facemask?
The FDA 510(k) record lists Sawbros Industries Pvt., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Reverse Pull Adjustable Facemask?
The FDA product code for Reverse Pull Adjustable Facemask is DZB.
相關臨床試驗
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相關器械（代碼：DZB）
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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