FDA 510(k) Application Details - K242152

Device Classification Name	Pump, Infusion, Elastomeric   More FDA Info for this Device
510(K) Number	K242152
Device Name	Pump, Infusion, Elastomeric
Applicant	Epic Medical Pte. Ltd. 105 Cecil Street #20-04, The Octagon Singapore 069534 SG Other 510(k) Applications for this Company
Contact	Freddie Lee Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2024
Decision Date	10/07/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review