FDA 510(k) Application Details - K193473

Device Classification Name	Recorder,Event,Implantable Cardiac,(With Arrhythmia Detection)   More FDA Info for this Device
510(K) Number	K193473
Device Name	Recorder,Event,Implantable Cardiac,(With Arrhythmia Detection)
Applicant	Boston Scientific Corporation 4100 Hamline Ave North St. Paul, MN 55112 US Other 510(k) Applications for this Company
Contact	Melissa Klamerus Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MXD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2019
Decision Date	06/26/2020
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