The following data is part of a premarket notification filed by Cambridge Heart, Inc. with the FDA for Heartwave Alternans Processing System, Model Aps.
| Device ID | K022152 |
| 510k Number | K022152 |
| Device Name: | HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS |
| 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 | 2002-07-02 |
| Decision Date | 2002-07-16 |
| Summary: | summary |