FDA 510(k)

iQ 2 鼻罩，幻影 2 鼻罩

K号: K211274 · 2022-01-10

决定日期2022-01-10

产品代码BZD

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

iQ 2 Nasal Mask, Phantom 2 Nasal 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 2022-01-10 under 510(k) number K211274. 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 iQ 2 Nasal Mask, Phantom 2 Nasal Mask?

iQ 2 Nasal Mask, Phantom 2 Nasal Mask is a medical device that received FDA 510(k) clearance on 2022-01-10. The listed applicant is Sleepnet Corporation. The 510(k) number is K211274.

When did iQ 2 Nasal Mask, Phantom 2 Nasal Mask receive FDA 510(k) clearance?

iQ 2 Nasal Mask, Phantom 2 Nasal Mask received FDA 510(k) clearance on 2022-01-10, under 510(k) number K211274.

Who is the listed applicant for iQ 2 Nasal Mask, Phantom 2 Nasal 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 iQ 2 Nasal Mask, Phantom 2 Nasal Mask?

The FDA product code for iQ 2 Nasal Mask, Phantom 2 Nasal 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。