FDA 510(k)

Ampa One System (AMPA-001)

K 號：K251210 · 2025-06-27

申請人Neuromodulatory Devices & Applications

決定日期2025-06-27

產品代碼OBP

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Ampa One System (AMPA-001) is the device name listed in this FDA 510(k) record. The listed applicant is Neuromodulatory Devices & Applications. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K251210. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ampa One System (AMPA-001)?

Ampa One System (AMPA-001) is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Neuromodulatory Devices & Applications. The 510(k) number is K251210.

When did Ampa One System (AMPA-001) receive FDA 510(k) clearance?

Ampa One System (AMPA-001) received FDA 510(k) clearance on 2025-06-27, under 510(k) number K251210.

Who is the listed applicant for Ampa One System (AMPA-001)?

The FDA 510(k) record lists Neuromodulatory Devices & Applications as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ampa One System (AMPA-001)?

The FDA product code for Ampa One System (AMPA-001) is OBP.

其他以 Neuromodulatory Devices & Applications 為申請人之記錄

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K243319Ampa One System (AMPA-001)

相關器械（代碼：OBP）

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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