A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K072593
Device Name A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE
Applicant
HEALTHSTATS INTERNATIONAL PTE. LTD.
s65 w35739 piper road
eagle, 
WI 
53119

Applicant Contact stephen gorski
Correspondent
HEALTHSTATS INTERNATIONAL PTE. LTD.
s65 w35739 piper road
eagle, 
WI 
53119

Correspodent Contact stephen gorski
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 09/14/2007
Decision Date 11/15/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No