The following data is part of a premarket notification filed by Cambridge Heart, Inc. with the FDA for Alternanas Processing System, Ch 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System.
Device ID | K012206 |
510k Number | K012206 |
Device Name: | ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM |
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 | 2001-07-13 |
Decision Date | 2001-10-12 |
Summary: | summary |