Cleared Special

DIGITAL PULSE OXIMETER, MODEL 7500

K071285 · Nonin Medical, Inc. · Anesthesiology
Jul 2007
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K071285 is an FDA 510(k) clearance for the DIGITAL PULSE OXIMETER, MODEL 7500, a Oximeter (Class II — Special Controls, product code DQA), submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 12, 2007, 66 days after receiving the submission on May 7, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K071285 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2007
Decision Date July 12, 2007
Days to Decision 66 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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