MyoStrain 5.1
K 號：K182756 · 2019-02-14
廣告
器材摘要
MyoStrain 5.1 is the device name listed in this FDA 510(k) record. The listed applicant is Myocardial Solutions. It received FDA 510(k) clearance on 2019-02-14 under 510(k) number K182756. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MyoStrain 5.1?
MyoStrain 5.1 is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is Myocardial Solutions. The 510(k) number is K182756.
When did MyoStrain 5.1 receive FDA 510(k) clearance?
MyoStrain 5.1 received FDA 510(k) clearance on 2019-02-14, under 510(k) number K182756.
Who is the listed applicant for MyoStrain 5.1?
The FDA 510(k) record lists Myocardial Solutions as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MyoStrain 5.1?
The FDA product code for MyoStrain 5.1 is LNH.
相關臨床試驗
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相關器械（代碼：LNH）
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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