Voyant System

Arthroscope

Viseon, Inc.

The following data is part of a premarket notification filed by Viseon, Inc. with the FDA for Voyant System.

Pre-market Notification Details

Device IDK191579
510k NumberK191579
Device Name:Voyant System
ClassificationArthroscope
Applicant Viseon, Inc. 13900 Alton Parkway, Suite 125 Irvine,  CA  92618
ContactCora Sim
CorrespondentCora Sim
Viseon, Inc. 13900 Alton Parkway, Suite 125 Irvine,  CA  92618
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-14
Decision Date2019-07-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00850007069155 K191579 000
00850007069148 K191579 000
00850007069001 K191579 000

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