FDA 510(k)

Simple T 儿童鼻罩

K号: K151120 · 2016-04-15

决定日期2016-04-15

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

Simple T Pediatric Nasal Mask is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K151120. 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 Simple T Pediatric Nasal Mask?

Simple T Pediatric Nasal Mask is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Respironics, Inc.. The 510(k) number is K151120.

When did Simple T Pediatric Nasal Mask receive FDA 510(k) clearance?

Simple T Pediatric Nasal Mask received FDA 510(k) clearance on 2016-04-15, under 510(k) number K151120.

Who is the listed applicant for Simple T Pediatric Nasal Mask?

FDA 510(k)记录中列出Respironics, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Simple T Pediatric Nasal Mask?

The FDA product code for Simple T Pediatric Nasal Mask is BZD.

列明Respironics, 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。

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