Fingertip Pulse Oximeter
Oximeter Plus - QuickCheck Pro
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
- 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 IdentifiersDevice Id: 00860298000089
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