Myo Plus
K 號：K191179 · 2019-09-04
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器材摘要
Myo Plus is the device name listed in this FDA 510(k) record. The listed applicant is Otto Bock Healthcare Products GmbH. It received FDA 510(k) clearance on 2019-09-04 under 510(k) number K191179. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Myo Plus?
Myo Plus is a medical device that received FDA 510(k) clearance on 2019-09-04. The listed applicant is Otto Bock Healthcare Products GmbH. The 510(k) number is K191179.
When did Myo Plus receive FDA 510(k) clearance?
Myo Plus received FDA 510(k) clearance on 2019-09-04, under 510(k) number K191179.
Who is the listed applicant for Myo Plus?
The FDA 510(k) record lists Otto Bock Healthcare Products GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Myo Plus?
The FDA product code for Myo Plus is GXY.
其他以 Otto Bock Healthcare Products GmbH 為申請人之記錄
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相關器械（代碼：GXY）
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
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