FDA 510(k) Application Details - K190548

Device Classification Name	Recorder,Event,Implantable Cardiac,(With Arrhythmia Detection)   More FDA Info for this Device
510(K) Number	K190548
Device Name	Recorder,Event,Implantable Cardiac,(With Arrhythmia Detection)
Applicant	Biotronik, Inc. 6024 Jean Road Lake Oswego, OR 97035 US Other 510(k) Applications for this Company
Contact	Jon Brumbaugh 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	03/05/2019
Decision Date	07/05/2019
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