FDA 510(k) Application Details - K233266

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K233266
Device Name	Electrocardiograph
Applicant	Mediblu Medical LLC 3016 NW 82nd Ave Doral, FL 33122 US Other 510(k) Applications for this Company
Contact	Fernando Ramon Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2023
Decision Date	06/12/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review