The following data is part of a premarket notification filed by Techmedic Development International B.v. with the FDA for Dyna-vision Telemonitoring System.
| Device ID | K152973 |
| 510k Number | K152973 |
| Device Name: | Dyna-Vision Telemonitoring System |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Techmedic Development International B.V. Broeker Werf 6 Broek Op Langedijk, NL 1721 Pc |
| Contact | Rutger Brest Van Kempen |
| Correspondent | Patsy J Trisler Qserve Group US Inc. P.O BOX 940 Charlestown, NH 03603 |
| Product Code | MHX |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSI |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-08 |
| Decision Date | 2016-04-29 |
| Summary: | summary |