Cleared Traditional

MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY

K113215 · Nonin Medical, Inc. · Cardiovascular
May 2012
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K113215 is an FDA 510(k) clearance for the MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY, a Oximeter, Tissue Saturation (Class II — Special Controls, product code MUD), submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 14, 2012, 195 days after receiving the submission on November 1, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K113215 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2011
Decision Date May 14, 2012
Days to Decision 195 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