MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM


Device Classification Name

computer, blood-pressure

510(k) Number K080670
Device Name MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
Applicant
ATCOR MEDICAL
11/1059-1063 victoria
road
west ryde nsw, 

AU

2114

Applicant Contact john abram
Correspondent
ATCOR MEDICAL
11/1059-1063 victoria
road
west ryde nsw, 

AU

2114

Correspodent Contact john abram
Regulation Number 870.1110
Classification Product Code
DSK  
Subsequent Product Code
DRT  
Date Received 03/10/2008
Decision Date 04/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No