Cleared Traditional

PULSE OXIMETER

K112843 · Nonin Medical, Inc. · Anesthesiology
Apr 2012
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K112843 is an FDA 510(k) clearance for the PULSE OXIMETER, a Oximeter (Class II — Special Controls, product code DQA), submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 19, 2012, 203 days after receiving the submission on September 29, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K112843 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2011
Decision Date April 19, 2012
Days to Decision 203 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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