Cardnav

FDA 510(k) K120282 · Paieon, Inc.

Substantially Equivalent

510(k) numberK120282

Submission

Device name
Cardnav
Applicant
Paieon, Inc.
Rosh Haayin, IL
Received
January 31, 2012
Decision date
December 10, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OWB – Interventional Fluoroscopic X-Ray System
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

Interventional fluoroscopy

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Questions and answers

When was Cardnav cleared by the FDA?

Cardnav (K120282) received a 510(k) decision of Substantially Equivalent on December 10, 2012, 314 days after the submission was received.

What is the product code of K120282?

The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.