The following data is part of a premarket notification filed by Cambridge Heart, Inc. with the FDA for Cambridge Heart Ch 2000 Cardiac Diagnostic System.
| Device ID | K981697 |
| 510k Number | K981697 |
| Device Name: | CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM |
| Classification | Electrocardiograph |
| Applicant | CAMBRIDGE HEART, INC. 1 OAK PARK DR. Bedford, MA 01730 -1413 |
| Contact | John D Greenbaum |
| Correspondent | John D Greenbaum CAMBRIDGE HEART, INC. 1 OAK PARK DR. Bedford, MA 01730 -1413 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-11 |
| Decision Date | 1998-10-14 |