AVITA ARM TYPE BLOOD PRESSURE MONITOR


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K112825
Device Name AVITA ARM TYPE BLOOD PRESSURE MONITOR
Applicant
AVITA CORPORATION
2904 n. boldt dr.
flagstaff, 
AZ 
86001

Applicant Contact jennifer reich
Correspondent
AVITA CORPORATION
2904 n. boldt dr.
flagstaff, 
AZ 
86001

Correspodent Contact jennifer reich
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 09/28/2011
Decision Date 01/18/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No