FDA 510(k)

Nimbl (型號 PD08-N1)

K 號：K234155 · 2024-06-21

決定日期2024-06-21

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

Nimbl (model PD08-N1) is the device name listed in this FDA 510(k) record. The listed applicant is Tactile Medical. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K234155. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nimbl (model PD08-N1)?

Nimbl (model PD08-N1) is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Tactile Medical. The 510(k) number is K234155.

When did Nimbl (model PD08-N1) receive FDA 510(k) clearance?

Nimbl (model PD08-N1) received FDA 510(k) clearance on 2024-06-21, under 510(k) number K234155.

Who is the listed applicant for Nimbl (model PD08-N1)?

FDA 510(k) 記錄將 Tactile Medical 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Nimbl (model PD08-N1)?

The FDA product code for Nimbl (model PD08-N1) is JOW.

其他以 Tactile Medical 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。

K253555Flexitouch® Plus 進階氣動壓迫系統 K252849AffloVest® 移動氣道清除治療

相關器械（代碼：JOW）

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。

K261807連續循環器（SC-4004-DL，SC-4008-DL）Bio Compression Systems, Inc.K254217AerloomEvolym, LLC K253555Flexitouch® Plus 進階氣動壓迫系統Tactile Medical K253386DVT 裝備Vistar Medical Supplies Co., Ltd.K250242壓力治療設備（LGT-2202DVT）Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.

官方來源

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