Hubble II
K 號：K163180 · 2016-12-29
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器材摘要
Hubble II is the device name listed in this FDA 510(k) record. The listed applicant is Orbbo Surgical, LLC. It received FDA 510(k) clearance on 2016-12-29 under 510(k) number K163180. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Hubble II?
Hubble II is a medical device that received FDA 510(k) clearance on 2016-12-29. The listed applicant is Orbbo Surgical, LLC. The 510(k) number is K163180.
When did Hubble II receive FDA 510(k) clearance?
Hubble II received FDA 510(k) clearance on 2016-12-29, under 510(k) number K163180.
Who is the listed applicant for Hubble II?
The FDA 510(k) record lists Orbbo Surgical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hubble II?
The FDA product code for Hubble II is MAX.
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其他以 Orbbo Surgical, LLC 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：MAX）
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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