FDA 510(k)

AIR前方陣列，AIR後方陣列

K 號：K172695 · 2017-11-22

申請人Ge Healthcare Coils (Usa Instruments, Inc.)

決定日期2017-11-22

產品代碼MOS

諮詢委員會RA

決定相當於

器材摘要

AIR Anterior Array, AIR Posterior Array 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 2017-11-22 under 510(k) number K172695. 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 AIR Anterior Array, AIR Posterior Array?

AIR Anterior Array, AIR Posterior Array is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K172695.

When did AIR Anterior Array, AIR Posterior Array receive FDA 510(k) clearance?

AIR Anterior Array, AIR Posterior Array received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172695.

Who is the listed applicant for AIR Anterior Array, AIR Posterior Array?

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 AIR Anterior Array, AIR Posterior Array?

The FDA product code for AIR Anterior Array, AIR Posterior Array 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。

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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。

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