FDA 510(k) Application Details - K221154

Device Classification Name	Infant Heel Warmer (Chemical Heat Pack)   More FDA Info for this Device
510(K) Number	K221154
Device Name	Infant Heel Warmer (Chemical Heat Pack)
Applicant	International Biomedical 8206 Cross Park Drive Austin, TX 78754 US Other 510(k) Applications for this Company
Contact	Amy Pieper Other 510(k) Applications for this Contact
Regulation Number	890.5710   More FDA Info for this Regulation Number
Classification Product Code	MPO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2022
Decision Date	10/07/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review