mb-FIX 頭部固定系統
K 號：K250423 · 2025-11-06
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器材摘要
mb-FIX Cranial Stabilization Systems is the device name listed in this FDA 510(k) record. The listed applicant is Medical Bees GmbH. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K250423. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the mb-FIX Cranial Stabilization Systems?
mb-FIX Cranial Stabilization Systems is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Medical Bees GmbH. The 510(k) number is K250423.
When did mb-FIX Cranial Stabilization Systems receive FDA 510(k) clearance?
mb-FIX Cranial Stabilization Systems received FDA 510(k) clearance on 2025-11-06, under 510(k) number K250423.
Who is the listed applicant for mb-FIX Cranial Stabilization Systems?
The FDA 510(k) record lists Medical Bees GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for mb-FIX Cranial Stabilization Systems?
The FDA product code for mb-FIX Cranial Stabilization Systems is HBL.
相關臨床試驗
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相關器械（代碼：HBL）
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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