FDA 510(k)

嬰兒足跟加熱器™；足跟親密者®

K 號：K221154 · 2022-10-07

決定日期2022-10-07

產品代碼MPO

諮詢委員會PM

決定相當於

器材摘要

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.

常見問題

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.

其他以 International Biomedical 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：MPO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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