Device Classification Name |
Plethysmograph, Impedance
|
510(k) Number |
K011439 |
Device Name |
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR |
Applicant |
CARDIODYNAMICS INTERNATIONAL CORP. |
6175 NANCY RIDGE DR., #300 |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
BRIAN PARK |
Correspondent |
CARDIODYNAMICS INTERNATIONAL CORP. |
6175 NANCY RIDGE DR., #300 |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
BRIAN PARK |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 05/10/2001 |
Decision Date | 11/02/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|