FDA 510(k)

慢波DS8

K 號：K191320 · 2020-10-02

決定日期2020-10-02

產品代碼LQZ

諮詢委員會DE

決定相當於

器材摘要

Slow Wave DS8 is the device name listed in this FDA 510(k) record. The listed applicant is Slow Wave, Inc.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K191320. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Slow Wave DS8?

Slow Wave DS8 is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Slow Wave, Inc.. The 510(k) number is K191320.

When did Slow Wave DS8 receive FDA 510(k) clearance?

Slow Wave DS8 received FDA 510(k) clearance on 2020-10-02, under 510(k) number K191320.

Who is the listed applicant for Slow Wave DS8?

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

What is the FDA product code for Slow Wave DS8?

The FDA product code for Slow Wave DS8 is LQZ.

其他以 Slow Wave, Inc. 為申請人之記錄

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K240463慢波DS8 (SWDS802)

相關器械（代碼：LQZ）

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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