Quantix/Nd Device

FDA 510(k) K023431 · Cardiosonix, Ltd.

Substantially Equivalent

510(k) numberK023431

Submission

Device name
Quantix/Nd Device
Applicant
Cardiosonix, Ltd.
Kfar Saba, IL
Received
October 15, 2002
Decision date
November 13, 2002
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DPW – Flowmeter, Blood, Cardiovascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2100
Specialty
Cardiovascular

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Questions and answers

When was Quantix/Nd Device cleared by the FDA?

Quantix/Nd Device (K023431) received a 510(k) decision of Substantially Equivalent on November 13, 2002, 29 days after the submission was received.

What is the product code of K023431?

The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.