Cleared Traditional

DIGITAL PULSE OXIMETER, MODEL 7500FO

K071415 · Nonin Medical, Inc. · Anesthesiology
Aug 2007
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K071415 is an FDA 510(k) clearance for the DIGITAL PULSE OXIMETER, MODEL 7500FO, a Oximeter (Class II — Special Controls, product code DQA), submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 8, 2007, 79 days after receiving the submission on May 21, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K071415 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2007
Decision Date August 08, 2007
Days to Decision 79 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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