Omnispec ED1000
K 號：K210166 · 2023-01-27
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器材摘要
Omnispec ED1000 is the device name listed in this FDA 510(k) record. The listed applicant is Medispec, Ltd.. It received FDA 510(k) clearance on 2023-01-27 under 510(k) number K210166. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Omnispec ED1000?
Omnispec ED1000 is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Medispec, Ltd.. The 510(k) number is K210166.
When did Omnispec ED1000 receive FDA 510(k) clearance?
Omnispec ED1000 received FDA 510(k) clearance on 2023-01-27, under 510(k) number K210166.
Who is the listed applicant for Omnispec ED1000?
The FDA 510(k) record lists Medispec, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Omnispec ED1000?
The FDA product code for Omnispec ED1000 is ISA.
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相關器械（代碼：ISA）
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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