VASOTRAC APM205A


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K011152
Device Name VASOTRAC APM205A
Original Applicant
MEDWAVE, INC.
4382 round lake rd. west
arden hills, 
MN 
55112 -3923

Original Contact donna r lunak
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 04/16/2001
Decision Date 05/31/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No