MODIFICATION TO: BPCARD, MODEL Z-7000-0700


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K073630
Device Name MODIFICATION TO: BPCARD, MODEL Z-7000-0700
Applicant
QRS DIAGNOSTIC, LLC.
14755 27th ave.north
plymouth, 
MN 
55447

Applicant Contact mary kay jensen
Correspondent
QRS DIAGNOSTIC, LLC.
14755 27th ave.north
plymouth, 
MN 
55447

Correspodent Contact mary kay jensen
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 12/26/2007
Decision Date 01/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No