FDA 510(k)

WiZARD 520 全脸罩

K号: K243023 · 2025-05-23

决定日期2025-05-23

产品代码BZD

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决定实质等同

器械摘要

WiZARD 520 Full Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Wellell, Inc.. It received FDA 510(k) clearance on 2025-05-23 under 510(k) number K243023. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the WiZARD 520 Full Face Mask?

WiZARD 520 Full Face Mask is a medical device that received FDA 510(k) clearance on 2025-05-23. The listed applicant is Wellell, Inc.. The 510(k) number is K243023.

When did WiZARD 520 Full Face Mask receive FDA 510(k) clearance?

WiZARD 520 Full Face Mask received FDA 510(k) clearance on 2025-05-23, under 510(k) number K243023.

Who is the listed applicant for WiZARD 520 Full Face Mask?

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

What is the FDA product code for WiZARD 520 Full Face Mask?

The FDA product code for WiZARD 520 Full Face Mask is BZD.

列明Wellell, 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。

K251466VenAir，顺序加压系统（9P-089000）；VenAir，顺序加压系统（PM01D01 / 小腿服装（S））；VenAir，顺序加压系统（PM01E01 / 小腿服装（M））；VenAir，顺序加压系统（PM01F01 / 小腿服装（L））；VenAir，顺序加压系统（PM01G01 / 大腿服装（S））；VenAir，顺序加压系统（PM01H01 / 大腿服装（M））；VenAir，顺序加压系统（PM01I01 / 大腿服装（L））；VenAir，顺序加压系统

官方来源

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