Ballancer Platinum (1222)
K 號：K230385 · 2023-04-04
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器材摘要
Ballancer Platinum (1222) is the device name listed in this FDA 510(k) record. The listed applicant is Mego Afek. It received FDA 510(k) clearance on 2023-04-04 under 510(k) number K230385. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Ballancer Platinum (1222)?
Ballancer Platinum (1222) is a medical device that received FDA 510(k) clearance on 2023-04-04. The listed applicant is Mego Afek. The 510(k) number is K230385.
When did Ballancer Platinum (1222) receive FDA 510(k) clearance?
Ballancer Platinum (1222) received FDA 510(k) clearance on 2023-04-04, under 510(k) number K230385.
Who is the listed applicant for Ballancer Platinum (1222)?
The FDA 510(k) record lists Mego Afek as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ballancer Platinum (1222)?
The FDA product code for Ballancer Platinum (1222) is IRP.
相關臨床試驗
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相關器械（代碼：IRP）
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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