Device Classification Name |
Transmitters And Receivers, Electrocardiograph, Telephone
|
510(k) Number |
K170506 |
Device Name |
ECG Check - Universal, ECG Check - Universal Plus |
Applicant |
Cardiac Designs, Inc. |
25510 Interstate 45 N |
Suite 202 |
Spring,
TX
77386
|
|
Applicant Contact |
James Tassone |
Correspondent |
CJP Consulting, Inc. |
5831 N Kostner Ave |
Chigaco,
IL
60646
|
|
Correspondent Contact |
Cynthia J. Pillar |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 02/21/2017 |
Decision Date | 10/02/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|