Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K010186 |
Device Name |
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM |
Applicant |
WELCH ALLYN, INC. |
95 OLD SHOALS RD. |
ARDEN,
NC
28704
|
|
Applicant Contact |
DAVID A YOUNG II |
Correspondent |
WELCH ALLYN, INC. |
95 OLD SHOALS RD. |
ARDEN,
NC
28704
|
|
Correspondent Contact |
DAVID A YOUNG II |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 01/22/2001 |
Decision Date | 06/08/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|