FDA 510(k)

Mojo 2 全脸通风口罩，Veraseal 3 全脸通风口罩，V3 全脸通风口罩

K号: K190254 · 2019-07-05

决定日期2019-07-05

产品代码BZD

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决定实质等同

器械摘要

Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask is the device name listed in this FDA 510(k) record. The listed applicant is Sleepnet Corporation. It received FDA 510(k) clearance on 2019-07-05 under 510(k) number K190254. 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 Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask?

Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask is a medical device that received FDA 510(k) clearance on 2019-07-05. The listed applicant is Sleepnet Corporation. The 510(k) number is K190254.

When did Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask receive FDA 510(k) clearance?

Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask received FDA 510(k) clearance on 2019-07-05, under 510(k) number K190254.

Who is the listed applicant for Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask?

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

What is the FDA product code for Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask?

The FDA product code for Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask is BZD.

列明Sleepnet Corporation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。

K251847Sleepnet Arie 全脸通风口罩；Sleepnet Arie 鼻通风口罩 K241830Mojo 全脸通风口罩；Veraseal 2 全脸通风口罩；Innova 全脸通风口罩；Ascend 全脸通风口罩 K241943Mojo 全脸非通风口罩；Veraseal 2 全脸非通风口罩；Veraseal 2 全脸 AAV 非通风口罩 K241661Mojo 2 全脸通风口罩；Veraseal 3 全脸通风口罩；V3 全脸通风口罩 K241520Mojo 2 全脸非通风口罩；Mojo 2 全脸 AAV 非通风口罩；Veraseal 3 全脸非通风口罩；Veraseal 3 全脸 AAV 非通风 K241469iQ 2 鼻部通气口罩；幻影 2 鼻部通气口罩

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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。