FDA 510(k)

空氣偵探 DL

K 號：K213717 · 2022-06-08

申請人Ge Medical Systems,Llc (Ge Healthcare)

決定日期2022-06-08

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

AIR Recon DL is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems,Llc (Ge Healthcare). It received FDA 510(k) clearance on 2022-06-08 under 510(k) number K213717. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

什麼是 AIR Recon DL？

AIR Recon DL is a medical device that received FDA 510(k) clearance on 2022-06-08. The listed applicant is Ge Medical Systems,Llc (Ge Healthcare). The 510(k) number is K213717.

AIR Recon DL 當時是於何時獲得 FDA 510(k) 識別許可的？

AIR Recon DL received FDA 510(k) clearance on 2022-06-08, under 510(k) number K213717.

誰是列出的 AIR Recon DL 該申請人？

The FDA 510(k) record lists Ge Medical Systems,Llc (Ge Healthcare) as the applicant. This does not by itself establish the device manufacturer.

FDA產品代碼是什麼？AIR Recon DL？

FDA產品代碼為AIR Recon DL的是LNH。

其他以 Ge Medical Systems,Llc (Ge Healthcare) 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。

K223523聲波DL

相關器械（代碼：LNH）

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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