Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K001543 |
Device Name |
BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 |
Applicant |
WELCH ALLYN, INC. |
4341 STATE ST. RD. |
P.O. BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Applicant Contact |
ZORAN PSENICNIK |
Correspondent |
WELCH ALLYN, INC. |
4341 STATE ST. RD. |
P.O. BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Correspondent Contact |
ZORAN PSENICNIK |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 05/17/2000 |
Decision Date | 01/29/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|