FDA 510(k) Application Details - K170506

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K170506
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	Cardiac Designs, Inc. 25510 Interstate 45 N Suite 202 Spring, TX 77386 US Other 510(k) Applications for this Company
Contact	James Tassone Other 510(k) Applications for this Contact
Regulation Number	870.2920   More FDA Info for this Regulation Number
Classification Product Code	DXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2017
Decision Date	10/02/2017
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