FDA 510(k)

Puffin Lite 婴儿复苏系统

K号: K182956 · 2019-01-18

决定日期2019-01-18

产品代码BTL

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决定实质等同

器械摘要

Puffin Lite Infant Resuscitation System is the device name listed in this FDA 510(k) record. The listed applicant is International Biomedical. It received FDA 510(k) clearance on 2019-01-18 under 510(k) number K182956. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Puffin Lite Infant Resuscitation System?

Puffin Lite Infant Resuscitation System is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is International Biomedical. The 510(k) number is K182956.

When did Puffin Lite Infant Resuscitation System receive FDA 510(k) clearance?

Puffin Lite Infant Resuscitation System received FDA 510(k) clearance on 2019-01-18, under 510(k) number K182956.

Who is the listed applicant for Puffin Lite Infant Resuscitation System?

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

What is the FDA product code for Puffin Lite Infant Resuscitation System?

The FDA product code for Puffin Lite Infant Resuscitation System is BTL.

列明International Biomedical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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官方来源

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