The following data is part of a premarket notification filed by Cambridge Heart, Inc. with the FDA for Cardiac Diagnostic System, Model Ch2000.
| Device ID | K013565 |
| 510k Number | K013565 |
| Device Name: | CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 |
| Classification | Electrocardiograph |
| Applicant | CAMBRIDGE HEART, INC. 20310 SW 48TH ST. Ft. Lauderdale, FL 33332 |
| Contact | John Greenbaum |
| Correspondent | John Greenbaum CAMBRIDGE HEART, INC. 20310 SW 48TH ST. Ft. Lauderdale, FL 33332 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-26 |
| Decision Date | 2001-11-21 |
| Summary: | summary |