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FDA 510(k)

MPowRx 鼻鼾解決方案（亦稱為Good Morning Snore Solution）

K 號：K193239 · 2020-01-03

申請人Mpowrx Health and Wellness Products 2012, Inc.
決定日期2020-01-03
產品代碼LRK
諮詢委員會DE
決定相當於

器材摘要

MPowRx Snoring Solution (also known as Good Morning Snore Solution) is the device name listed in this FDA 510(k) record. The listed applicant is Mpowrx Health and Wellness Products 2012, Inc.. It received FDA 510(k) clearance on 2020-01-03 under 510(k) number K193239. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MPowRx Snoring Solution (also known as Good Morning Snore Solution)?

MPowRx Snoring Solution (also known as Good Morning Snore Solution) is a medical device that received FDA 510(k) clearance on 2020-01-03. The listed applicant is Mpowrx Health and Wellness Products 2012, Inc.. The 510(k) number is K193239.

When did MPowRx Snoring Solution (also known as Good Morning Snore Solution) receive FDA 510(k) clearance?

MPowRx Snoring Solution (also known as Good Morning Snore Solution) received FDA 510(k) clearance on 2020-01-03, under 510(k) number K193239.

Who is the listed applicant for MPowRx Snoring Solution (also known as Good Morning Snore Solution)?

The FDA 510(k) record lists Mpowrx Health and Wellness Products 2012, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MPowRx Snoring Solution (also known as Good Morning Snore Solution)?

The FDA product code for MPowRx Snoring Solution (also known as Good Morning Snore Solution) is LRK.

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相關器械（代碼：LRK）

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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