QUANTIX/OR DEVICE— 510(k) K030357

Substantially Equivalent

Cardiosonix, Ltd.

FDA 510(k) clearance K030357 for QUANTIX/OR DEVICE, Substantially Equivalent on 2003-08-20. 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: 2003-02-03
Decision date: 2003-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
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.