步驟-1 PumEtch
K 號：K213093 · 2022-01-28
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器材摘要
STEP-1 PumEtch is the device name listed in this FDA 510(k) record. The listed applicant is Rounding Third, LLC. It received FDA 510(k) clearance on 2022-01-28 under 510(k) number K213093. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the STEP-1 PumEtch?
STEP-1 PumEtch is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Rounding Third, LLC. The 510(k) number is K213093.
When did STEP-1 PumEtch receive FDA 510(k) clearance?
STEP-1 PumEtch received FDA 510(k) clearance on 2022-01-28, under 510(k) number K213093.
Who is the listed applicant for STEP-1 PumEtch?
The FDA 510(k) record lists Rounding Third, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for STEP-1 PumEtch?
The FDA product code for STEP-1 PumEtch is KLE.
相關臨床試驗
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相關器械（代碼：KLE）
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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