The following data is part of a premarket notification filed by Cardioline S.p.a with the FDA for Cardioline Hd+.
| Device ID | K150289 |
| 510k Number | K150289 |
| Device Name: | CARDIOLINE HD+ |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | CARDIOLINE S.p.A Via De Zinis, 6 Cavareno, TN 38011 |
| Contact | Emanuele Ercoli |
| Correspondent | Emanuele Ercoli CARDIOLINE S.p.A Via De Zinis, 6 Cavareno, TN 38011 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-05 |
| Decision Date | 2015-08-27 |
| Summary: | summary |