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FDA 510(k)

3.0T Air MP M,3.0T Air MP L

K 號:K182504 · 2018-10-12

決定日期2018-10-12
產品代碼MOS
諮詢委員會RA
決定相當於

器材摘要

3.0T Air MP M, 3.0T Air MP L is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K182504. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 3.0T Air MP M, 3.0T Air MP L?

3.0T Air MP M, 3.0T Air MP L is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K182504.

When did 3.0T Air MP M, 3.0T Air MP L receive FDA 510(k) clearance?

3.0T Air MP M, 3.0T Air MP L received FDA 510(k) clearance on 2018-10-12, under 510(k) number K182504.

Who is the listed applicant for 3.0T Air MP M, 3.0T Air MP L?

The FDA 510(k) record lists Ge Healthcare Coils (Usa Instruments, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3.0T Air MP M, 3.0T Air MP L?

The FDA product code for 3.0T Air MP M, 3.0T Air MP L is MOS.

其他以 Ge Healthcare Coils (Usa Instruments, Inc.) 為申請人之記錄

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。

相關器械(代碼:MOS)

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

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