The following data is part of a premarket notification filed by Cambridge Heart, Inc. with the FDA for Heartwave Ii Cardiac Diagnostic System.
| Device ID | K050225 |
| 510k Number | K050225 |
| Device Name: | HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | CAMBRIDGE HEART, INC. 20310 SW 48TH ST. Southwest Ranches, FL 33332 |
| Contact | John Greenbaum |
| Correspondent | John Greenbaum CAMBRIDGE HEART, INC. 20310 SW 48TH ST. Southwest Ranches, FL 33332 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-01 |
| Decision Date | 2005-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522121852 | K050225 | 000 |
| 10841522121845 | K050225 | 000 |
| 10841522121814 | K050225 | 000 |
| 10841522121913 | K050225 | 000 |