SIGNA Voyager
K 號：K161567 · 2016-09-01
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器材摘要
SIGNA Voyager is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K161567. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SIGNA Voyager?
SIGNA Voyager is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is GE Healthcare. The 510(k) number is K161567.
When did SIGNA Voyager receive FDA 510(k) clearance?
SIGNA Voyager received FDA 510(k) clearance on 2016-09-01, under 510(k) number K161567.
Who is the listed applicant for SIGNA Voyager?
The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SIGNA Voyager?
The FDA product code for SIGNA Voyager is LNH.
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其他以 GE Healthcare 為申請人之記錄
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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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