FDA 510(k)

塞瑞娜睡眠下巴前移器（BMA），塞瑞娜睡眠彈性下巴前移器（EMA）

K 號：K203606 · 2021-03-10

決定日期2021-03-10

產品代碼LRK

諮詢委員會DE

決定相當於

器材摘要

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) is the device name listed in this FDA 510(k) record. The listed applicant is Meris Investment Group. It received FDA 510(k) clearance on 2021-03-10 under 510(k) number K203606. 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 Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)?

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) is a medical device that received FDA 510(k) clearance on 2021-03-10. The listed applicant is Meris Investment Group. The 510(k) number is K203606.

When did Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) receive FDA 510(k) clearance?

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) received FDA 510(k) clearance on 2021-03-10, under 510(k) number K203606.

Who is the listed applicant for Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)?

The FDA 510(k) record lists Meris Investment Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)?

The FDA product code for Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) is LRK.

其他以 Meris Investment Group 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。

K230495塞瑞娜睡眠護牙器

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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官方來源

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