FDA 510(k) Application Details - K170154

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K170154
Device Name	Electrocardiograph
Applicant	Creavo Medical Technologies, Ltd. 2020 House, Siskin Drive, Middlemarch Business Park Coventry cv3 4fj GB Other 510(k) Applications for this Company
Contact	David Dimambro 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	01/18/2017
Decision Date	10/12/2017
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