自動外用除颤器（非佩戴式）
PMA 核准號：P160032 · 2026-08-25
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器材摘要
Automated external defibrillators (non-wearable) is the device name listed in this FDA 510(k) record. The listed applicant is Defibtech, LLC. It received FDA 510(k) clearance on 2026-08-25. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements.
常見問題
What is the Automated external defibrillators (non-wearable)?
Automated external defibrillators (non-wearable) is a medical device that received FDA 510(k) clearance on 2026-08-25. The listed applicant is Defibtech, LLC.
When did Automated external defibrillators (non-wearable) receive FDA 510(k) clearance?
The clearance date for Automated external defibrillators (non-wearable) can be found in the official FDA records.
誰是自動外用除颤器（非穿戴式）的列名申請人？
The FDA 510(k) record lists Defibtech, LLC as the applicant. This does not by itself establish the device manufacturer.
FDA產品代碼是什麼？(自動外用除颤器[非可佩戴型])？
FDA產品代碼為自動外用除颤器（非穿戴式）的是MKJ。這屬於牙科類別。
相關臨床試驗
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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