Device Classification Name |
plethysmograph, impedance
|
510(k) Number |
K051228 |
Device Name |
BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG |
Applicant |
CARDIODYNAMICS INTERNATIONAL CORP. |
6175 NANCY RIDGE DR., #300 |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
DENNIS HEPP |
Correspondent |
CARDIODYNAMICS INTERNATIONAL CORP. |
6175 NANCY RIDGE DR., #300 |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
DENNIS HEPP |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 05/13/2005 |
Decision Date | 06/10/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|