The following data is part of a premarket notification filed by Cardiobiomedical Corporation with the FDA for Cardio Spectrum Diagnostic System (csd).
| Device ID | K042849 |
| 510k Number | K042849 |
| Device Name: | CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD) |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | CARDIOBIOMEDICAL CORPORATION 2 BRIAR LANE Natick, MA 01760 |
| Contact | James F Mongigardo |
| Correspondent | James F Mongigardo CARDIOBIOMEDICAL CORPORATION 2 BRIAR LANE Natick, MA 01760 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-15 |
| Decision Date | 2005-01-13 |