Cleared Special

EVISION DATA MANAGEMENT SOFTWARE

K092678 · Nonin Medical, Inc. · Anesthesiology
Oct 2009
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K092678 is an FDA 510(k) clearance for the EVISION DATA MANAGEMENT SOFTWARE, a Oximeter (Class II — Special Controls, product code DQA), submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 1, 2009, 30 days after receiving the submission on September 1, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K092678 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2009
Decision Date October 01, 2009
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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