Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K152973 |
Device Name |
Dyna-Vision Telemonitoring System |
Applicant |
Techmedic Development International B.V. |
Broeker Werf 6 |
Broek op Langedijk,
NL
1721 PC
|
|
Applicant Contact |
Rutger Brest van Kempen |
Correspondent |
Qserve Group US Inc. |
P.O BOX 940 |
Charlestown,
NH
03603
|
|
Correspondent Contact |
Patsy J Trisler |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/08/2015 |
Decision Date | 04/29/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|