T-Stat 2.0 微血管組織脈搏血氧計
K 號：K192322 · 2019-09-23
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器材摘要
T-Stat 2.0 Microvascular Tissue Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Spectros Corporation. It received FDA 510(k) clearance on 2019-09-23 under 510(k) number K192322. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the T-Stat 2.0 Microvascular Tissue Oximeter?
T-Stat 2.0 Microvascular Tissue Oximeter is a medical device that received FDA 510(k) clearance on 2019-09-23. The listed applicant is Spectros Corporation. The 510(k) number is K192322.
When did T-Stat 2.0 Microvascular Tissue Oximeter receive FDA 510(k) clearance?
T-Stat 2.0 Microvascular Tissue Oximeter received FDA 510(k) clearance on 2019-09-23, under 510(k) number K192322.
Who is the listed applicant for T-Stat 2.0 Microvascular Tissue Oximeter?
The FDA 510(k) record lists Spectros Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for T-Stat 2.0 Microvascular Tissue Oximeter?
The FDA product code for T-Stat 2.0 Microvascular Tissue Oximeter is MUD.
相關臨床試驗
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相關器械（代碼：MUD）
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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