QUANTIX/ND DEVICE


Device Classification Name

flowmeter, blood, cardiovascular

510(k) Number K023431
Device Name QUANTIX/ND DEVICE
Original Applicant
CARDIOSONIX, LTD.
beit hapa’amon (box 124)
20 hata’as st.
kfar saba, 

IL

44425

Original Contact ahava stein
Regulation Number 870.2100
Classification Product Code
DPW  
Date Received 10/15/2002
Decision Date 11/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No