健康OST
K 號：K213944 · 2022-04-22
廣告
器材摘要
HealthOST is the device name listed in this FDA 510(k) record. The listed applicant is Nanoxai , Ltd.. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K213944. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the HealthOST?
HealthOST is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Nanoxai , Ltd.. The 510(k) number is K213944.
When did HealthOST receive FDA 510(k) clearance?
HealthOST received FDA 510(k) clearance on 2022-04-22, under 510(k) number K213944.
Who is the listed applicant for HealthOST?
The FDA 510(k) record lists Nanoxai , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HealthOST?
The FDA product code for HealthOST is JAK.
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：JAK）
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。
K261125BodyTom 64 (NL4100)；OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA 觀察階段 6.0Fujifilm CorporationK253836FCT iStream 階段 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770卡迪克套件GE Medical Systems SCSK253560強化版PCCT邊界Ge Medical Systems, LLC
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。
廣告