The following data is part of a premarket notification filed by H&c Medical Devices Spa with the FDA for Ab Cardiette Daedalus View Base And Ab Cardiettte Daedalus View Hes.
| Device ID | K002074 |
| 510k Number | K002074 |
| Device Name: | AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES |
| Classification | Electrocardiograph |
| Applicant | H&C MEDICAL DEVICES SPA VIA PISA 250 20099 SESTO SAN GIOVANNI Milan, IT |
| Contact | Attilio Castelli |
| Correspondent | Attilio Castelli H&C MEDICAL DEVICES SPA VIA PISA 250 20099 SESTO SAN GIOVANNI Milan, IT |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-10 |
| Decision Date | 2000-10-04 |