FDA 510(k)

NM-01/CPT神經電位計（NM-01/CPT）

K 號：K240189 · 2025-03-26

申請人Mde Orvosbiológiai Kutató, Fejleszto,

決定日期2025-03-26

產品代碼JXE

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

NM-01/CPT neurometer (NM-01/CPT) is the device name listed in this FDA 510(k) record. The listed applicant is Mde Orvosbiológiai Kutató, Fejleszto,. It received FDA 510(k) clearance on 2025-03-26 under 510(k) number K240189. The device is classified under product code JXE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NM-01/CPT neurometer (NM-01/CPT)?

NM-01/CPT neurometer (NM-01/CPT) is a medical device that received FDA 510(k) clearance on 2025-03-26. The listed applicant is Mde Orvosbiológiai Kutató, Fejleszto,. The 510(k) number is K240189.

When did NM-01/CPT neurometer (NM-01/CPT) receive FDA 510(k) clearance?

NM-01/CPT neurometer (NM-01/CPT) received FDA 510(k) clearance on 2025-03-26, under 510(k) number K240189.

Who is the listed applicant for NM-01/CPT neurometer (NM-01/CPT)?

The FDA 510(k) record lists Mde Orvosbiológiai Kutató, Fejleszto, as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NM-01/CPT neurometer (NM-01/CPT)?

The FDA product code for NM-01/CPT neurometer (NM-01/CPT) is JXE.

相關器械（代碼：JXE）

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。

K190536Mediracer NCSMediracer OY

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。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：JXE）

官方來源