Vivio System

FDA 510(k) K183710 · Avicena, LLC

Substantially Equivalent

510(k) numberK183710

Submission

Device name
Vivio System
Applicant
Avicena, LLC
Altadena, CA, US
Received
December 31, 2018
Decision date
October 4, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQD – Stethoscope, Electronic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1875
Specialty
Cardiovascular

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Questions and answers

When was Vivio System cleared by the FDA?

Vivio System (K183710) received a 510(k) decision of Substantially Equivalent on October 4, 2019, 277 days after the submission was received.

What is the product code of K183710?

The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.