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N-395 Pulse Oximeter

by Nellcor Puritan Bennett, Inc. 510(k)

Active United States

510(k) K993637

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK993637 Date24 Nov 1999ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0665-05 FDA Unclassified (pre-2012) initiated 18 Oct 2004

    The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.

Specification

510(k)

Full name
N-395 Pulse Oximeter, with Extended Device Claims
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, 25 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 N-395 Pulse Oximeter is a non-invasive device designed for the continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients in hospital-type facilities and intra-hospital settings, including those with well or poorly perfused conditions.

The device is supplied as a single-use or reusable unit, depending on the model, and is regulated under FDA 510(k) clearance. It requires proper storage and handling to maintain functionality, and its use should follow the manufacturer's guidelines for operation and maintenance.

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Questions

AI-generated answers, 25 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 N-395 Pulse Oximeter used for?

    This device is a non-invasive tool designed for the continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients in hospital-type facilities and intra-hospital settings.

  • Is the Nellcor N-395 Pulse Oximeter single-use or reusable?

    The device is supplied as a single-use or reusable unit, depending on the specific model. The manufacturer's guidelines should be followed to determine the appropriate usage for your specific device.

  • How is the Nellcor N-395 Pulse Oximeter regulated?

    The Nellcor N-395 Pulse Oximeter is regulated under FDA 510(k) clearance. This regulatory route indicates that the device has been submitted to the FDA as substantially equivalent to a predicate device.