Stethoflux

FDA 510(k) K060064 · Odvi

Substantially Equivalent

510(k) numberK060064

Submission

Device name
Stethoflux
Applicant
Odvi
Orsay, FR
Received
January 9, 2006
Decision date
April 10, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAF – Monitor, Ultrasonic, Nonfetal
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1540
Specialty
Radiology

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K063600Vista AvsJAF · Traditional Summit Doppler Systems, Inc.12/19/2006SE
K052067Doppler Guided Proctoscope, Model 500HJAF · Traditional Multigon Industries, Inc.08/29/2005SE
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Questions and answers

When was Stethoflux cleared by the FDA?

Stethoflux (K060064) received a 510(k) decision of Substantially Equivalent on April 10, 2006, 91 days after the submission was received.

What is the product code of K060064?

The FDA product code is JAF – Monitor, Ultrasonic, Nonfetal, a Class II (moderate risk) device regulated under 21 CFR 892.1540.