Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K040490 |
FOIA Releasable 510(k) |
K040490
|
Device Name |
WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE |
Applicant |
WELCH ALLYN, INC. |
4341 STATE ST. RD. |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Correspondent |
WELCH ALLYN, INC. |
4341 STATE ST. RD. |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 02/26/2004 |
Decision Date | 08/18/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|