The following data is part of a premarket notification filed by Cambridge Heart, Inc. with the FDA for Analytic Spectral Method Of Alternans Processing; Ch 2000 Cardiac Diagnostic System; Heartwave Alternans Processing Sys.
| Device ID | K003492 |
| 510k Number | K003492 |
| Device Name: | ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS |
| Classification | Computer, Diagnostic, Programmable |
| 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 | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-13 |
| Decision Date | 2001-01-18 |