The following data is part of a premarket notification filed by S & W Medico Teknik A/s with the FDA for Diascope Traveller Plus (4053).
| Device ID | K964593 |
| 510k Number | K964593 |
| Device Name: | DIASCOPE TRAVELLER PLUS (4053) |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | S & W MEDICO TEKNIK A/S HERSTEDVANG 8 Albertslund, DK Dk-2620 |
| Contact | Carsten W Jenson |
| Correspondent | Carsten W Jenson S & W MEDICO TEKNIK A/S HERSTEDVANG 8 Albertslund, DK Dk-2620 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-15 |
| Decision Date | 1997-06-30 |