Infant Heel WarmerTM; Heel Snuggler®— 510(k) K221154

Name: FDA 510(k) clearance K221154
Creator: U.S. Food and Drug Administration
Published: 2022-10-07

Substantially Equivalent

International Biomedical

FDA 510(k) clearance K221154 for Infant Heel WarmerTM; Heel Snuggler®, Substantially Equivalent on 2022-10-07. Applicant: International Biomedical. Device class: 1.

Clearance details

Applicant: International Biomedical
Product code: Code MPO
Device class: Class 1
Regulation: 21 CFR 890.5710
Advisory panel: Physical Medicine
Date received: 2022-04-21
Decision date: 2022-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MPO

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K151845 — Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)2016-03-18
K150627 — Rapid Aid Instant Disposable Infant Heel Warmer2015-05-27
K103549 — DENOVO TEDDY GEL INFANT HEEL WARMER2011-04-08
K053254 — INFANT HEEL WARMER BY INTCO2006-09-19
K040856 — RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER2004-05-03

More clearances from International Biomedical

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K221653 — InfaTherm Disposable Infant Warming Mattress2022-10-06
K220742 — NxtGen Infant Transport Incubator2022-07-15
K193481 — AeroNOx 2.0 Nitric Oxide Titration & Monitoring System2020-03-10
K182956 — Puffin Lite Infant Resuscitation System2019-01-18
K173516 — NuBorne Infant Warmer2018-08-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.