Cleared Traditional

PULSE OXIMETER

K102350 · Nonin Medical, Inc. · Anesthesiology
Dec 2010
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K102350 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 December 22, 2010, 125 days after receiving the submission on August 19, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K102350 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2010
Decision Date December 22, 2010
Days to Decision 125 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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