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 |
10841522118432 | K050225 | 000 |
10841522118449 | K050225 | 000 |
10841522118456 | K050225 | 000 |
10841522123832 | K050225 | 000 |
10841522121920 | K050225 | 000 |
10841522121913 | K050225 | 000 |
10841522121814 | K050225 | 000 |
10841522121845 | K050225 | 000 |
10841522118425 | K050225 | 000 |