FDA 510(k)

婴儿足跟保暖器TM；足跟舒适器®

K号: K221154 · 2022-10-07

决定日期2022-10-07

产品代码MPO

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决定实质等同

器械摘要

Infant Heel WarmerTM; Heel Snuggler® is the device name listed in this FDA 510(k) record. The listed applicant is International Biomedical. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K221154. The device is classified under product code MPO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Infant Heel WarmerTM; Heel Snuggler®?

Infant Heel WarmerTM; Heel Snuggler® is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is International Biomedical. The 510(k) number is K221154.

When did Infant Heel WarmerTM; Heel Snuggler® receive FDA 510(k) clearance?

Infant Heel WarmerTM; Heel Snuggler® received FDA 510(k) clearance on 2022-10-07, under 510(k) number K221154.

Who is the listed applicant for Infant Heel WarmerTM; Heel Snuggler®?

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 Infant Heel WarmerTM; Heel Snuggler®?

The FDA product code for Infant Heel WarmerTM; Heel Snuggler® is MPO.

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。

K221653InfaTherm 一次性婴儿保暖床垫 K220742NxtGen婴儿转运培养箱 K193481AeroNOx 2.0 氧化亚氮滴定与监控系统 K182956Puffin Lite 婴儿复苏系统 K173516NuBorne 婴儿保暖器 K160238Airborne光疗灯

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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。