微膠膠劑/利多卡因
K 號：K211943 · 2024-10-17
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器材摘要
Microlyte Ag/Lidocaine is the device name listed in this FDA 510(k) record. The listed applicant is Imbed Biosciences. It received FDA 510(k) clearance on 2024-10-17 under 510(k) number K211943. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the Microlyte Ag/Lidocaine?
Microlyte Ag/Lidocaine is a medical device that received FDA 510(k) clearance on 2024-10-17. The listed applicant is Imbed Biosciences. The 510(k) number is K211943.
When did Microlyte Ag/Lidocaine receive FDA 510(k) clearance?
Microlyte Ag/Lidocaine received FDA 510(k) clearance on 2024-10-17, under 510(k) number K211943.
Who is the listed applicant for Microlyte Ag/Lidocaine?
The FDA 510(k) record lists Imbed Biosciences as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Microlyte Ag/Lidocaine?
The FDA product code for Microlyte Ag/Lidocaine is FRO. This falls under the Anesthesiology category.
相關臨床試驗
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相關器械（代碼：FRO）
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。
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。
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