FDA 510(k)

歐洲藥品管理局3D

K 號：K232735 · 2024-05-03

決定日期2024-05-03

產品代碼LRK

諮詢委員會DE

決定相當於

器材摘要

EMA 3D is the device name listed in this FDA 510(k) record. The listed applicant is Ema Sleep Incorporated. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K232735. 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 EMA 3D?

EMA 3D is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Ema Sleep Incorporated. The 510(k) number is K232735.

When did EMA 3D receive FDA 510(k) clearance?

EMA 3D received FDA 510(k) clearance on 2024-05-03, under 510(k) number K232735.

Who is the listed applicant for EMA 3D?

The FDA 510(k) record lists Ema Sleep Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMA 3D?

The FDA product code for EMA 3D is LRK.

相關器械（代碼：LRK）

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官方來源

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