Device Classification Name |
Electrocardiograph
|
510(k) Number |
K143436 |
Device Name |
InvisionECG System |
Applicant |
InvisionHeart Inc. |
121 17th Avenue South |
Nashville,
TN
37203
|
|
Applicant Contact |
Michael Wurst |
Correspondent |
Speed to Market, Inc. |
PO Box 3018 |
Nederland,
CO
80466
|
|
Correspondent Contact |
Thomas Kroenke |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 12/01/2014 |
Decision Date | 05/21/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|