Cleared Traditional

Intra.Ox Handheld Tissue Oximeter

K163472 · Vioptix, Inc. · Cardiovascular
Nov 2017
Decision
339d
Days
Class 2
Risk

About This 510(k) Submission

K163472 is an FDA 510(k) clearance for the Intra.Ox Handheld Tissue Oximeter, a Oximeter, Tissue Saturation (Class II — Special Controls, product code MUD), submitted by Vioptix, Inc. (Newark, US). The FDA issued a Cleared decision on November 16, 2017, 339 days after receiving the submission on December 12, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K163472 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2016
Decision Date November 16, 2017
Days to Decision 339 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MUD — Oximeter, Tissue Saturation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700