FDA 510(k)

Leva 盆腔健康系統

K 號：K212495 · 2021-09-08

決定日期2021-09-08

產品代碼HIR

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

Leva Pelvic Health System is the device name listed in this FDA 510(k) record. The listed applicant is Renovia, Inc.. It received FDA 510(k) clearance on 2021-09-08 under 510(k) number K212495. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Leva Pelvic Health System?

Leva Pelvic Health System is a medical device that received FDA 510(k) clearance on 2021-09-08. The listed applicant is Renovia, Inc.. The 510(k) number is K212495.

When did Leva Pelvic Health System receive FDA 510(k) clearance?

Leva Pelvic Health System received FDA 510(k) clearance on 2021-09-08, under 510(k) number K212495.

Who is the listed applicant for Leva Pelvic Health System?

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

What is the FDA product code for Leva Pelvic Health System?

The FDA product code for Leva Pelvic Health System is HIR.

其他以 Renovia, 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。

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相關器械（代碼：HIR）

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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