INTRA. OX HANDHELD TISSUE OXIMETER

Oximeter, Tissue Saturation

VIOPTIX INC.

The following data is part of a premarket notification filed by Vioptix Inc. with the FDA for Intra. Ox Handheld Tissue Oximeter.

Pre-market Notification Details

Device IDK133983
510k NumberK133983
Device Name:INTRA. OX HANDHELD TISSUE OXIMETER
ClassificationOximeter, Tissue Saturation
Applicant VIOPTIX INC. 3722 AVE. SAUSALITO Irvine,  CA  92606
ContactGreg Holland
CorrespondentGreg Holland
VIOPTIX INC. 3722 AVE. SAUSALITO Irvine,  CA  92606
Product CodeMUD  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-27
Decision Date2014-09-12
Summary:summary

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