iSpO2 Pulse Oximeter Consumer (Large)

iSpO2 Pulse Oximeter Consumer (Large) - 3587

A small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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

Code: PGJ

Device Name: Oximeter, Wellness

Device Class: 2

Physical State: Used to transmit light at known wavelengths(s) through blood using a light emitting diode(s) and sensor.

Definition: Pulse oximeter intended for wellness use.

Submission Type ID: 7

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Transmit light at a known wavelength(s) through blood to measure photoplethysmographic data based on the amount of reflected or scattered light.

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 Id: 00843997007719

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