SPECTRALMD 深視傷口成像系統 2.0
K 號：K163339 · 2017-08-17
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器材摘要
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Spectralmd, Inc.. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K163339. The device is classified under product code DPT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0?
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Spectralmd, Inc.. The 510(k) number is K163339.
When did SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 receive FDA 510(k) clearance?
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 received FDA 510(k) clearance on 2017-08-17, under 510(k) number K163339.
Who is the listed applicant for SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0?
The FDA 510(k) record lists Spectralmd, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0?
The FDA product code for SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 is DPT.
相關臨床試驗
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相關器械（代碼：DPT）
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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