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Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring System, Nellcor Bedside SPO2 Patien

by Covidien, Formerly Nellcor Puritan Bennett, Inc. 510(k)

Active United States

510(k) K123581

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123581 Date9 May 2013ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2267-2015 FDA Class II initiated 29 Jun 2015
    • Terminated Z-2268-2015 FDA Class II initiated 29 Jun 2015

    Potential missing segments on the display that can result in misinterpretation of data.

Specification

510(k)

510(k) Number
FDA Product Code
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Nellcor OxiMax N-600x is a bedside pulse oximeter designed for respiratory patient monitoring. It measures oxygen saturation levels and pulse rate using OxiMax technology.

The device is supplied with a pulse oximetry cable, operator's manual, and power cord. It is intended for use in clinical settings and has received FDA 510(k) clearance as substantially equivalent.

Other devices from Covidien, Formerly Nellcor Puritan Bennett, Inc.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Nellcor OxiMax N-600x pulse oximeter used for?

    The Nellcor OxiMax N-600x is a bedside pulse oximeter designed for respiratory patient monitoring. It measures oxygen saturation levels and pulse rate using OxiMax technology in clinical settings.

  • What components are supplied with the Nellcor OxiMax N-600x pulse oximeter?

    The device is supplied with a pulse oximetry cable, operator's manual, and power cord. These components are essential for proper setup and operation of the monitoring system.

  • What regulatory clearance has the Nellcor OxiMax N-600x pulse oximeter received?

    The device has received FDA 510(k) clearance as substantially equivalent. This means it has been determined to be as safe and effective as legally marketed predicate devices.

  • Is the Nellcor OxiMax N-600x pulse oximeter reusable or single-use?

    The device is a bedside monitoring system designed for repeated use in clinical settings. It is not a single-use device and should be maintained according to the manufacturer's instructions.