FUKUDA DENSHI VASERA MODEL VS-1500


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K112521
Device Name FUKUDA DENSHI VASERA MODEL VS-1500
Applicant
FUKUDA DENSHI USA, INC.
17725 n.e. 65th st., bldg. c
redmond, 
WA 
98052 -4911

Applicant Contact doug blakely
Correspondent
FUKUDA DENSHI USA, INC.
17725 n.e. 65th st., bldg. c
redmond, 
WA 
98052 -4911

Correspodent Contact doug blakely
Regulation Number 870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DQC   JOO  
Date Received 08/31/2011
Decision Date 12/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No