The following data is part of a premarket notification filed by Et Medical Devices Spa with the FDA for Cardioline Ar 600, Ar 1200, Ar 2100.
| Device ID | K051534 |
| 510k Number | K051534 |
| Device Name: | CARDIOLINE AR 600, AR 1200, AR 2100 |
| Classification | Electrocardiograph |
| Applicant | ET MEDICAL DEVICES SPA VIA DE ZINIS 6 Cavareno, IT 38011 |
| Contact | Attilio Castelli |
| Correspondent | Attilio Castelli ET MEDICAL DEVICES SPA VIA DE ZINIS 6 Cavareno, IT 38011 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-10 |
| Decision Date | 2005-10-05 |
| Summary: | summary |