Device Classification Name |
Instrument, Coagulation
|
510(k) Number |
K050821 |
Device Name |
COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM |
Applicant |
ZYCARE |
3804 SWEETEN CREEK RD. |
CHAPEL HILL,
NC
27514
|
|
Applicant Contact |
STEVE D HOLDAWAY |
Correspondent |
ZYCARE |
3804 SWEETEN CREEK RD. |
CHAPEL HILL,
NC
27514
|
|
Correspondent Contact |
STEVE D HOLDAWAY |
Regulation Number | 864.5400
|
Classification Product Code |
|
Date Received | 03/31/2005 |
Decision Date | 08/16/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|