The following data is part of a premarket notification filed by Cambridge Heart, Inc. with the FDA for Cardiac Diagnostic System Model Ch 2000.
Device ID | K983102 |
510k Number | K983102 |
Device Name: | CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000 |
Classification | Computer, Diagnostic, Programmable |
Applicant | CAMBRIDGE HEART, INC. 20310 SW 48TH ST. Ft. Lauderdale, FL 33332 |
Contact | John D Greenbaum |
Correspondent | John D 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 | 1998-09-03 |
Decision Date | 1999-04-12 |
Summary: | summary |