Cardiac Designs Inc

FDA Filings

This page includes the latest FDA filings for Cardiac Designs Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010665082
• FEI Number: 3010665082
• Name: CARDIAC DESIGNS INC
• Owner & Operator: Cardiac Designs Inc
• Contact Address: 3804 Helios Way ; Pflugerville TX 78660 US
• Official Correspondent:
  • Karim Marroush
  • 001-435-6476467-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3804 Helios Way ; Pflugerville, TX 78660 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID B287ECG01U0 CARDIAC DESIGNS INC.	ECG Check ECG01-Universal	2018-07-06
PMN K170506 | DXH CARDIAC DESIGNS INC	ECG Check Universal	2018-02-08
PMN K170506 Cardiac Designs, Inc.	ECG Check - Universal, ECG Check - Universal Plus	2017-10-02
PMN K131045 | DQK CARDIAC DESIGNS INC	Enterprise ECG Analysis/Interpretation Software	2016-12-06
PMN K131045 | DPS CARDIAC DESIGNS INC	Enterprise ECG Analysis/Interpretation Software	2016-12-06
PMN K122184 | DXH CARDIAC DESIGNS INC	ECG Check	2013-05-06