Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K781517 |
Device Name |
AUTOMATIC BLOOD PRESSURE DEVICE |
Applicant |
WELCH ALLYN, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
WELCH ALLYN, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 09/01/1978 |
Decision Date | 01/11/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|