QUANTIX/ND DEVICE— 510(k) K023431

Substantially Equivalent

Cardiosonix, Ltd.

FDA 510(k) clearance K023431 for QUANTIX/ND DEVICE, Substantially Equivalent on 2002-11-13. Applicant: Cardiosonix, Ltd.. Device class: 2.

Clearance details

Applicant: Cardiosonix, Ltd.
Product code: Product code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 2002-10-15
Decision date: 2002-11-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.