FDA 510(k)

Maxxi 噪鼾感測器

K 號：K191095 · 2020-01-16

決定日期2020-01-16

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

Maxxi Snore Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Neurovirtual USA, Inc.. It received FDA 510(k) clearance on 2020-01-16 under 510(k) number K191095. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Maxxi Snore Sensor?

Maxxi Snore Sensor is a medical device that received FDA 510(k) clearance on 2020-01-16. The listed applicant is Neurovirtual USA, Inc.. The 510(k) number is K191095.

When did Maxxi Snore Sensor receive FDA 510(k) clearance?

Maxxi Snore Sensor received FDA 510(k) clearance on 2020-01-16, under 510(k) number K191095.

Who is the listed applicant for Maxxi Snore Sensor?

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

What is the FDA product code for Maxxi Snore Sensor?

The FDA product code for Maxxi Snore Sensor is MNR.

其他以 Neurovirtual USA, Inc. 為申請人之記錄

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