FDA 510(k)

Hushd Pro Avera

K 號：K232025 · 2024-05-09

決定日期2024-05-09

產品代碼LRK

諮詢委員會DE

決定相當於

器材摘要

Hushd Pro Avera is the device name listed in this FDA 510(k) record. The listed applicant is Good Sleep CO Pte , Ltd.. It received FDA 510(k) clearance on 2024-05-09 under 510(k) number K232025. 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 Hushd Pro Avera?

Hushd Pro Avera is a medical device that received FDA 510(k) clearance on 2024-05-09. The listed applicant is Good Sleep CO Pte , Ltd.. The 510(k) number is K232025.

When did Hushd Pro Avera receive FDA 510(k) clearance?

Hushd Pro Avera received FDA 510(k) clearance on 2024-05-09, under 510(k) number K232025.

Who is the listed applicant for Hushd Pro Avera?

The FDA 510(k) record lists Good Sleep CO Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hushd Pro Avera?

The FDA product code for Hushd Pro Avera is LRK.

其他以 Good Sleep CO Pte , Ltd. 為申請人之記錄

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K252161Hushd Avera K251784Hushd Pro Z-Link

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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