Cleared Special

REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES

K092101 · Nonin Medical, Inc. · Anesthesiology
Oct 2009
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K092101 is an FDA 510(k) clearance for the REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES, a Oximeter (Class II — Special Controls, product code DQA), submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 21, 2009, 99 days after receiving the submission on July 14, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K092101 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2009
Decision Date October 21, 2009
Days to Decision 99 days
Submission Type Special
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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