Cleared Special

FINGER PULSE OXIMETER, MODEL 9560

K081285 · Nonin Medical, Inc. · Anesthesiology
Jun 2008
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K081285 is an FDA 510(k) clearance for the FINGER PULSE OXIMETER, MODEL 9560, a Oximeter (Class II — Special Controls, product code DQA), submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 5, 2008, 30 days after receiving the submission on May 6, 2008. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K081285 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2008
Decision Date June 05, 2008
Days to Decision 30 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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