Infant Heel WarmerTM; Heel Snuggler®
K-Number: K221154 · 2022-10-07
ApplicantInternational Biomedical
Decision Date2022-10-07
Product CodeMPO
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Infant Heel WarmerTM; Heel Snuggler® is a medical device manufactured by International Biomedical. It received FDA 510(k) clearance on 2022-10-07 under approval number K221154. The device is classified under product code MPO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by International Biomedical. The 510(k) number is K221154.
When was Infant Heel WarmerTM; Heel Snuggler® approved by the FDA?
Infant Heel WarmerTM; Heel Snuggler® received FDA 510(k) clearance on 2022-10-07, under approval number K221154.
What company makes Infant Heel WarmerTM; Heel Snuggler®?
Infant Heel WarmerTM; Heel Snuggler® is manufactured by International Biomedical.
What is the FDA product code for Infant Heel WarmerTM; Heel Snuggler®?
The FDA product code for Infant Heel WarmerTM; Heel Snuggler® is MPO.
Other Devices by International Biomedical
Related Devices (Code: MPO)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.