Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K002115 |
Device Name |
A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS |
Applicant |
A & D ENGINEERING, INC. |
1555 MC CANDLESS DR. |
MILPITAS,
CA
95035
|
|
Applicant Contact |
JERRY WANG |
Correspondent |
CITECH |
5200 BUTLER PIKE |
PLYMOUTH MEETING,
PA
19462 -1298
|
|
Correspondent Contact |
ROBERT MOSENKIS |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 07/13/2000 |
Decision Date | 07/25/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|