FDA 510(k)

慢波DS8 (SWDS802)

K 號：K240463 · 2024-06-04

決定日期2024-06-04

產品代碼MQC

決定相當於

器材摘要

Slow Wave DS8 (SWDS802) 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 2024-06-04 under 510(k) number K240463. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常見問題

What is the Slow Wave DS8 (SWDS802)?

Slow Wave DS8 (SWDS802) is a medical device that received FDA 510(k) clearance on 2024-06-04. The listed applicant is Slow Wave, Inc.. The 510(k) number is K240463.

When did Slow Wave DS8 (SWDS802) receive FDA 510(k) clearance?

Slow Wave DS8 (SWDS802) received FDA 510(k) clearance on 2024-06-04, under 510(k) number K240463.

Who is the listed applicant for Slow Wave DS8 (SWDS802)?

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 (SWDS802)?

The FDA product code for Slow Wave DS8 (SWDS802) is MQC.

其他以 Slow Wave, Inc. 為申請人之記錄

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K191320慢波DS8

相關器械（代碼：MQC）

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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