BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K023078
Device Name BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR
Original Applicant
VSM MEDTECH LTD.
675 west hastings st., 15th fl
vancouver, b.c., 

CA

v6b 1n2

Original Contact daryl wisdahl
Regulation Number 870.1130
Classification Product Code
DXN  
Subsequent Product Code
FLL  
Date Received 09/16/2002
Decision Date 03/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No