FDA 510(k)

OTS 25-L (100-5)

K 號：K241234 · 2025-01-23

決定日期2025-01-23

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

OTS 25-L (100-5) is the device name listed in this FDA 510(k) record. The listed applicant is Ots Medical , Ltd.. It received FDA 510(k) clearance on 2025-01-23 under 510(k) number K241234. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OTS 25-L (100-5)?

OTS 25-L (100-5) is a medical device that received FDA 510(k) clearance on 2025-01-23. The listed applicant is Ots Medical , Ltd.. The 510(k) number is K241234.

When did OTS 25-L (100-5) receive FDA 510(k) clearance?

OTS 25-L (100-5) received FDA 510(k) clearance on 2025-01-23, under 510(k) number K241234.

Who is the listed applicant for OTS 25-L (100-5)?

The FDA 510(k) record lists Ots Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTS 25-L (100-5)?

The FDA product code for OTS 25-L (100-5) is MBI.

其他以 Ots Medical , Ltd. 為申請人之記錄

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。

K251310OTS 25-L (100-5)K233429OTS 25 (100-1)

相關器械（代碼：MBI）

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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官方來源

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