Cleared Traditional

INTRA. OX HANDHELD TISSUE OXIMETER

K133983 · Vioptix, Inc. · Cardiovascular
Sep 2014
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K133983 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. (Irvine, US). The FDA issued a Cleared decision on September 12, 2014, 259 days after receiving the submission on December 27, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K133983 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2013
Decision Date September 12, 2014
Days to Decision 259 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