非處方自動式外用除颤器
PMA 核准號：P160029 · 2026-02-02
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決定日期2026-02-02
PMA 編號P160029
產品代碼NSA
器械分類3 類
醫療專科C
法規編號21 CFR 8
諮詢委員會履歷
器材摘要
Over-the-counter automated external defibrillator is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-02-02. The device is classified under product code NSA. It was reviewed by the CV advisory panel.
常見問題
What is the Over-the-counter automated external defibrillator?
Over-the-counter automated external defibrillator is a medical device that received FDA 510(k) clearance on 2026-02-02. The listed applicant is Philips Medical Systems, Inc..
When did Over-the-counter automated external defibrillator receive FDA 510(k) clearance?
The clearance date for Over-the-counter automated external defibrillator can be found in the official FDA records.
Who is the listed applicant for Over-the-counter automated external defibrillator?
The FDA 510(k) record lists Philips Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Over-the-counter automated external defibrillator?
The FDA product code for Over-the-counter automated external defibrillator is NSA.
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官方來源
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