FDA 510(k)

InfaTherm 一次性婴儿保暖床垫

K号: K221653 · 2022-10-06

决定日期2022-10-06

产品代码IMD

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决定实质等同

器械摘要

InfaTherm Disposable Infant Warming Mattress is the device name listed in this FDA 510(k) record. The listed applicant is International Biomedical. It received FDA 510(k) clearance on 2022-10-06 under 510(k) number K221653. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the InfaTherm Disposable Infant Warming Mattress?

InfaTherm Disposable Infant Warming Mattress is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is International Biomedical. The 510(k) number is K221653.

When did InfaTherm Disposable Infant Warming Mattress receive FDA 510(k) clearance?

InfaTherm Disposable Infant Warming Mattress received FDA 510(k) clearance on 2022-10-06, under 510(k) number K221653.

Who is the listed applicant for InfaTherm Disposable Infant Warming Mattress?

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 InfaTherm Disposable Infant Warming Mattress?

The FDA product code for InfaTherm Disposable Infant Warming Mattress is IMD.

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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