MightySat Medical

MightySat Medical
MightySat Medical - 5356

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OLK

Device Name: Pulse Oximeter For Over-The-Counter Use

Device Class: 2

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

Definition: Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device transmits radiation at a known wavelength(s) through blood and measures the blood oxygen saturation based on the amount of reflected or scattered radiation.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Peripheral circulatory pulse.

Regulation Number: 870.2700

Third Party Flag: N

Medical Specialty: CV

Device Id: 00843997005111

Device Type: Direct Marking

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

Device Id: 00843997017961

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