FDA 510(k)

nvc (注意：原文 "device_name medical-device regulatory text" 中的 "device_name" 沒有提供具體名稱，因此我將其翻譯為 "設備名稱"。若 "device_name" 是一個特定的產品名稱，則應保留原樣。以下為翻譯內容：) 設備名稱醫療設備規範文本政策：醫療規範-v1 FDA、510(k)、PMA、NCT、PMID、識別碼和網址請保持原樣。

K 號：K170074 · 2017-01-24

決定日期2017-01-24

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

nvc is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2017-01-24 under 510(k) number K170074. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the nvc?

nvc is a medical device that received FDA 510(k) clearance on 2017-01-24. The listed applicant is Nvision Biomedical Technologies, LLC. The 510(k) number is K170074.

When did nvc receive FDA 510(k) clearance?

nvc received FDA 510(k) clearance on 2017-01-24, under 510(k) number K170074.

Who is the listed applicant for nvc?

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

What is the FDA product code for nvc?

The FDA product code for nvc is ODP.