MMSphere
K 號:K190443 · 2019-06-24
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器材摘要
MMSphere is the device name listed in this FDA 510(k) record. The listed applicant is Galactic Beauty, LLC. It received FDA 510(k) clearance on 2019-06-24 under 510(k) number K190443. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MMSphere?
MMSphere is a medical device that received FDA 510(k) clearance on 2019-06-24. The listed applicant is Galactic Beauty, LLC. The 510(k) number is K190443.
When did MMSphere receive FDA 510(k) clearance?
MMSphere received FDA 510(k) clearance on 2019-06-24, under 510(k) number K190443.
Who is the listed applicant for MMSphere?
The FDA 510(k) record lists Galactic Beauty, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MMSphere?
The FDA product code for MMSphere is OHS.
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相關器械(代碼:OHS)
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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