SpiroHome Personal，SpiroHome 醫院
K 號：K213754 · 2023-06-12
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器材摘要
SpiroHome Personal, SpiroHome Clinic is the device name listed in this FDA 510(k) record. The listed applicant is Inofab Saglik Teknolojileri A.S. It received FDA 510(k) clearance on 2023-06-12 under 510(k) number K213754. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SpiroHome Personal, SpiroHome Clinic?
SpiroHome Personal, SpiroHome Clinic is a medical device that received FDA 510(k) clearance on 2023-06-12. The listed applicant is Inofab Saglik Teknolojileri A.S. The 510(k) number is K213754.
When did SpiroHome Personal, SpiroHome Clinic receive FDA 510(k) clearance?
SpiroHome Personal, SpiroHome Clinic received FDA 510(k) clearance on 2023-06-12, under 510(k) number K213754.
Who is the listed applicant for SpiroHome Personal, SpiroHome Clinic?
The FDA 510(k) record lists Inofab Saglik Teknolojileri A.S as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SpiroHome Personal, SpiroHome Clinic?
The FDA product code for SpiroHome Personal, SpiroHome Clinic is BZG.
相關臨床試驗
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：BZG）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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