InfaTherm Disposable Infant Warming Mattress
K-Number: K221653 · 2022-10-06
ApplicantInternational Biomedical
Decision Date2022-10-06
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
InfaTherm Disposable Infant Warming Mattress is a medical device manufactured by International Biomedical. It received FDA 510(k) clearance on 2022-10-06 under approval number K221653. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by International Biomedical. The 510(k) number is K221653.
When was InfaTherm Disposable Infant Warming Mattress approved by the FDA?
InfaTherm Disposable Infant Warming Mattress received FDA 510(k) clearance on 2022-10-06, under approval number K221653.
What company makes InfaTherm Disposable Infant Warming Mattress?
InfaTherm Disposable Infant Warming Mattress is manufactured by International Biomedical.
What is the FDA product code for InfaTherm Disposable Infant Warming Mattress?
The FDA product code for InfaTherm Disposable Infant Warming Mattress is IMD.
Other Devices by International Biomedical
Related Devices (Code: IMD)
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.