MightySat, Bluetooth, PVI, RRp, Fingertip Pulse Oximeter

MightySat, Bluetooth, PVI, RRp, Fingertip Pulse Oximeter - 9900

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

No Data Available

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: 00843997009379

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