Device Classification Name |
Electrocardiograph
|
510(k) Number |
K021171 |
Device Name |
Q-STRESS ECHO BED |
Applicant |
MEDICAL POSITIONING, INC. |
21911 ERIE LN. |
LAKE FOREST,
CA
92630
|
|
Applicant Contact |
CAROL PATTERSON |
Correspondent |
MEDICAL POSITIONING, INC. |
21911 ERIE LN. |
LAKE FOREST,
CA
92630
|
|
Correspondent Contact |
CAROL PATTERSON |
Regulation Number | 870.2340 |
Classification Product Code |
|
Date Received | 04/12/2002 |
Decision Date | 05/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|