MAKO 7
K 號：K160510 · 2016-06-09
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決定日期2016-06-09
產品代碼HIH
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
MAKO 7 is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Medical Corporation. It received FDA 510(k) clearance on 2016-06-09 under 510(k) number K160510. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MAKO 7?
MAKO 7 is a medical device that received FDA 510(k) clearance on 2016-06-09. The listed applicant is Nvision Medical Corporation. The 510(k) number is K160510.
When did MAKO 7 receive FDA 510(k) clearance?
MAKO 7 received FDA 510(k) clearance on 2016-06-09, under 510(k) number K160510.
Who is the listed applicant for MAKO 7?
The FDA 510(k) record lists Nvision Medical Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MAKO 7?
The FDA product code for MAKO 7 is HIH.
相關器械（代碼：HIH）
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