QUANTIX/OR DEVICE


Device Classification Name

flowmeter, blood, cardiovascular

510(k) Number K030357
Device Name QUANTIX/OR 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 02/03/2003
Decision Date 08/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No