FDA 510(k)

IRIS 體積凝固儀及數位式阴道鏡

K 號：K202915 · 2021-04-23

決定日期2021-04-23

產品代碼HGI

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

IRIS Thermocoagulator and Digital Colposcope is the device name listed in this FDA 510(k) record. The listed applicant is Liger Medical, LLC. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K202915. The device is classified under product code HGI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IRIS Thermocoagulator and Digital Colposcope?

IRIS Thermocoagulator and Digital Colposcope is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Liger Medical, LLC. The 510(k) number is K202915.

When did IRIS Thermocoagulator and Digital Colposcope receive FDA 510(k) clearance?

IRIS Thermocoagulator and Digital Colposcope received FDA 510(k) clearance on 2021-04-23, under 510(k) number K202915.

Who is the listed applicant for IRIS Thermocoagulator and Digital Colposcope?

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

What is the FDA product code for IRIS Thermocoagulator and Digital Colposcope?

The FDA product code for IRIS Thermocoagulator and Digital Colposcope is HGI.

其他以 Liger Medical, LLC 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。

K152843Liger醫療HTU-110

相關器械（代碼：HGI）

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。

K152843Liger醫療HTU-110Liger Medical, LLC

官方來源

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