MFG-05
K 號:K230780 · 2023-10-05
廣告
器材摘要
MFG-05 is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Medizinsysteme GmbH. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K230780. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MFG-05?
MFG-05 is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is Zimmer Medizinsysteme GmbH. The 510(k) number is K230780.
When did MFG-05 receive FDA 510(k) clearance?
MFG-05 received FDA 510(k) clearance on 2023-10-05, under 510(k) number K230780.
Who is the listed applicant for MFG-05?
The FDA 510(k) record lists Zimmer Medizinsysteme GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MFG-05?
The FDA product code for MFG-05 is KPI.
其他以 Zimmer Medizinsysteme GmbH 為申請人之記錄
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。
相關器械(代碼:KPI)
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。
K262353BTL-299-FBTL Industries, Inc.K260178骨盆肌肉訓練器(KM510、KM516B)Shenzhen Konmed Technology Co., Ltd.K252601骨盆肌肉訓練器(PC22A);骨盆肌肉訓練器(PC22A-L);骨盆肌肉訓練器(PC22E);骨盆肌肉訓練器(PC22E-L)Hunan Accurate Bio-Medical Technology Co., Ltd.K252552骨盆底復健治療設備(PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831骨盆底治療裝置 (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER 盆腔功能磁刺激器(PELVIPOWER 盆腔FMS)(033-0-1100-02)Pontemedag
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。
廣告