FDA 510(k)

CT-STOR 注意：根據政策「medical-regulatory-v1」，公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址應保持不變。上述翻譯中，已保留所有指定不變的元素。

K 號：K201789 · 2021-09-20

決定日期2021-09-20

產品代碼NDS

諮詢委員會GU

決定相當於

器材摘要

CT-STOR is the device name listed in this FDA 510(k) record. The listed applicant is Energy Delivery Solutions. It received FDA 510(k) clearance on 2021-09-20 under 510(k) number K201789. The device is classified under product code NDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CT-STOR?

CT-STOR is a medical device that received FDA 510(k) clearance on 2021-09-20. The listed applicant is Energy Delivery Solutions. The 510(k) number is K201789.

When did CT-STOR receive FDA 510(k) clearance?

CT-STOR received FDA 510(k) clearance on 2021-09-20, under 510(k) number K201789.

Who is the listed applicant for CT-STOR?

The FDA 510(k) record lists Energy Delivery Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT-STOR?

The FDA product code for CT-STOR is NDS.

相關器械（代碼：NDS）

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。

K232543MSC SFMYocon Biology Technology Company K240247“MoFi”細胞培養基礎培養基Duogenic Stemcells Corporation K231804PRIME-XV FreezIS DMSO-Free 非DMSO MDFujifilm Irvine Scientific

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。