FDA 510(k)

塔斯卡普羅系統（Pad-105）

K 號：K240296 · 2024-05-09

決定日期2024-05-09

產品代碼PLP

諮詢委員會GU

決定相當於

器材摘要

Tulsa Pro System (Pad-105) is the device name listed in this FDA 510(k) record. The listed applicant is Profound Medical, Inc.. It received FDA 510(k) clearance on 2024-05-09 under 510(k) number K240296. The device is classified under product code PLP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tulsa Pro System (Pad-105)?

Tulsa Pro System (Pad-105) is a medical device that received FDA 510(k) clearance on 2024-05-09. The listed applicant is Profound Medical, Inc.. The 510(k) number is K240296.

When did Tulsa Pro System (Pad-105) receive FDA 510(k) clearance?

Tulsa Pro System (Pad-105) received FDA 510(k) clearance on 2024-05-09, under 510(k) number K240296.

Who is the listed applicant for Tulsa Pro System (Pad-105)?

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

What is the FDA product code for Tulsa Pro System (Pad-105)?

The FDA product code for Tulsa Pro System (Pad-105) is PLP.

其他以 Profound Medical, Inc. 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。

K230692TULSA-PRO系統 K211858TULSA-PRO系統 K202286Tulsa-Pro 系統 K191200TULSA-PRO系統

相關器械（代碼：PLP）

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。

K251910Focal One®Edap Technomed, Inc.K231378Exablate 模型 2100V1，Exablate 前列腺系統，Exablate MRgFUS，Exablate 2100V1 型號 3.0Insightec, Ltd.K230692TULSA-PRO系統Profound Medical, Inc.K211858TULSA-PRO系統Profound Medical, Inc.K212150Exablate Prostate SystemInsightec, Inc.K202286Tulsa-Pro 系統Profound Medical, Inc.

官方來源

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