Device Classification Name |
Computer, Diagnostic, Programmable
|
510(k) Number |
K953127 |
Device Name |
ACCUSTRESS EXERCISE TESTING SYSTEM |
Applicant |
HEWLETT-PACKARD CO. |
1700 SOUTH BAKER ST. |
MCMINNVILLE,
OR
97128
|
|
Applicant Contact |
NANCY WINN |
Correspondent |
HEWLETT-PACKARD CO. |
1700 SOUTH BAKER ST. |
MCMINNVILLE,
OR
97128
|
|
Correspondent Contact |
NANCY WINN |
Regulation Number | 870.1425 |
Classification Product Code |
|
Date Received | 07/05/1995 |
Decision Date | 02/29/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|