FDA 510(k) Application Details - K210758

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K210758
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	Medicalgorithmics S.A. Aleje Jerozolimskie 81 Warsaw 02-001 PL Other 510(k) Applications for this Company
Contact	Maciej Gamrot Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2021
Decision Date	06/02/2022
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