Fingertip Pulse Oximeter

Product Overview

Fingertip Pulse Oximeter
Oximeter Plus - QuickCheck

Device Description

An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 158.00
    • -13.00

  • Device Sizes

    No Data Available

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: OCH

    Device Name: Oximeter, Infrared, Sporting, Aviation

    Device Class: 2

    Physical State: sports watch that emits infrared

    Definition: Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise.

    Submission Type ID: 7

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Non-invasive infrared

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Circulatory pulse

    Regulation Number: 870.2700

    Third Party Flag: N

    Medical Specialty: CV

    Device Identifiers

    Device Id: 00860298000096

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A

    Educational Resources