FDA 510(k)

AirSurgN充氣器(10030/AirSurgN)

K 號：K242772 · 2025-04-11

決定日期2025-04-11

產品代碼HIF

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

AirSurgN Insufflator (10030/AirSurgN) is the device name listed in this FDA 510(k) record. The listed applicant is SmartsurgN, Inc.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K242772. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AirSurgN Insufflator (10030/AirSurgN)?

AirSurgN Insufflator (10030/AirSurgN) is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is SmartsurgN, Inc.. The 510(k) number is K242772.

When did AirSurgN Insufflator (10030/AirSurgN) receive FDA 510(k) clearance?

AirSurgN Insufflator (10030/AirSurgN) received FDA 510(k) clearance on 2025-04-11, under 510(k) number K242772.

Who is the listed applicant for AirSurgN Insufflator (10030/AirSurgN)?

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

What is the FDA product code for AirSurgN Insufflator (10030/AirSurgN)?

The FDA product code for AirSurgN Insufflator (10030/AirSurgN) is HIF.

其他以 SmartsurgN, 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。

K242163智能手術視覺系統

相關器械（代碼：HIF）

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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