FDA 510(k) Application Details - K182571

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K182571
Device Name	Electrocardiograph
Applicant	Genetesis Inc. 5412 Courseview Drive, Suite 150 Mason, OH 45040 US Other 510(k) Applications for this Company
Contact	Robert Sokolowski 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	09/18/2018
Decision Date	03/15/2019
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