AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K030230
Device Name AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)
Original Applicant
AVITA CORPORATION
3892 south america west trail,
flaggstaff, 
AZ 
86001

Original Contact jennifer reich
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 01/22/2003
Decision Date 05/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No