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FDA 510(k)

慢波DS8 (SWDS802)

K号: K240463 · 2024-06-04

决定日期2024-06-04
产品代码MQC
决定实质等同

器械摘要

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.

常见问题

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.

列明Slow Wave, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

相关器械(代码:MQC)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

官方来源

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数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。

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