FDA 510(k) Application Details - K193104

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K193104
Device Name	Detector And Alarm, Arrhythmia
Applicant	Medicalgorithmics S.A. Aleje Jerozolimskie 81 Warsaw 02-001 PL Other 510(k) Applications for this Company
Contact	Marek Dziubinski Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	DSI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2019
Decision Date	04/09/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review