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MySign® S is a handheld pulse oximeter with accessory sensors indicated for continuous non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, and mobile transport units. For professional use only.

The EnviteC MySign® S Pulse Oximeter is a handheld pulse oximeter monitor validated for use in portable applications, including out of hospital transport. The MySign® S Pulse Oximeter features large readable numeric displays for SpO2 and pulse rate and a pulse bar indicator or waveform for visual assessment of pulsation. The device has settable alarms and an audible pulse tone which varies with saturation level. The MySign® S is offered with a family of Reusable and Disposable SpO2 Sensors for adult and pediatric applications. MySign® PC Software may be used to obtain retrospective monitoring data from MySign® series monitors and to perform utility functions such as setting the institution identification.

The oxygen measuring device MySign® O is designed for continuous or spot monitoring of inspired oxygen concentrations in breathing gas. MySign® O can be used for monitoring the breathing gases dispensed by the following devices: Anaesthesia breathing systems Respiratory equipment Infant incubators Oxygen therapy systems The system is suitable for use inside hospitals as well as during transport (except by air), emergencies, and artificial respiration provided at home.

The EnviteC MySign® O Oxygen Measuring Device is a hand held oxygen monitor which uses the established technology of the EnviteC electrogalvanic oxygen sensor type OOM111. The EnviteC OOM111 medical oxygen sensor has been previously evaluated and cleared under 510(k) K082655. The MySign® O Oxygen Measuring Device incorporates a medical oxygen sensor placed in the inspired air path or gas supply, a sensor cable, and a monitor to display the measurements. The device is intended for continuous or spot monitoring of inspired oxygen concentrations in breathing gas and provides settable low and high alarm limits. The optional MySign® PC Software can be used to configure MySign® devices and to transmit data from the device to the PC for the readout of measurement data which is stored in the memory of MySign® monitor. The PC software is not intended for diagnostic functions nor will it influence essential performance functions of the monitor - the MySign® O monitor will not perform measurements when PC connected.

EnviteC Reusable SpO2 Sensors are indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, mobile units and home environments.

The EnviteC Reusable SpO2 Sensors type Nihon Kohden are pulse oximeter sensors designed and validated for compatibility with the predicate oximeter manufacturer. EnviteC's Reusable SpO2 Sensors type Nihon Kohden are comprised of a connector and a cable which terminates into a sensor housing. One housing half contains a dual LED light source, and the other half contains a light sensitive photodetector for pulse oximetry by transmittance method. Two types of sensor housings are offered in this submission: - A soft rubber finger sensor with unitary sealed tube type construction (two sizes: large and medium) - An ear clip with rigid halves positioned by mild spring force and an ear hanger for the cable Each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer. Each sensor type includes the following features: - Connector pin-outs specific for the manufacturer type - Component specifications specific for the manufacture type Each sensor clearly specifies the manufacturer type with two compatibility statements: - One printed on or attached to the sensor - One on the instructions for use.

EnviteC Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, mobile units and home environments. Prescription device.

The EnviteC Reusable SpO2 Sensors are a family of oximeter sensors designed and validated for compatibility with the predicate oximeter manufacturers listed above. EnviteC's Reusable SpO2 Sensors are comprised of a connector and a cable which terminates into a sensor housing. One housing half contains a dual LED light source, and the other half contains a light sensitive photodetector for pulse oximetry by transmittance method. Three types of sensor housings are offered in this submission: A finger clip with rigid halves positioned by mild spring force, An ear clip with rigid halves positioned by mild spring force and an I ear hanger for the cable, I A soft rubber finger sensor with unitary sealed tube type construction. A unique sensor type exists for each compatible manufacturer above, and each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (HP/Philips, Minolta). Each sensor type includes the following features: r Connector pin-outs specific for the manufacturer type, Component specifications specific for the manufacture type. Each sensor clearly specifies the manufacturer type with two compatibility statements: One printed on or attached to the sensor r, 트 One on the instructions for use.

The EnviteC Medical Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The subject of this 510(k) is a family of EnviteC Medical Oxygen Sensors which may be used as industry replacement types with various medical inspired-oxygen measuring devices. The EnviteC Medical Oxygen Sensors all utilize the commonly accepted electro-galvanic operating principle with defined variations in the mounting configuration and electrical connections to correspond to common industry family replacement types.

The EnviteC OxiPen Pulse Oximeter is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate (measured by SpO2 sensor accessories). The monitor is intended for use on adult and pediatric patients in hospitals, hospital-type facilities, mobile, and home environments.

The OxiPen Pulse Oximeter is a compact battery-powered handheld monitor designed for simplicity and portability for spot checking applications. It does not provide alarms or settable alarm limits. The OxiPen features large readable numeric displays for SpO2 and pulse rate and a pulse bar indicator for visual assessment of pulsation. Additional indicators include a signal quality LED and heart symbol which show pulsation, a sensor symbol for disconnection alert, and a battery capacity symbol. Like the referenced predicate device, the OxiPen provides an audible pulse tone which varies with saturation level, as well as audible and visual alerts for conditions like sensor disconnect and power-off. The LCD display may be backlit by briefly pressing any key. The OxiPen is provided with sensors specifically designed for use with the device, and features a compact connector with EnviteC proprietary pinout. The EnviteC OxiPen Pulse Oximeter and accessory sensors employ the same technological characteristics as the predicate device and other oximeters to determine functional arterial oxygen saturation - arterially perfused tissue is illuminated sequentially by two wavelengths of light emitted by light emitting diodes (LED's), and the time varying absorbance of the tissue is measured from a photodiode light sensor. The resultant electrical signal is amplified, digitized, and analyzed to determine the functional oxygen saturation and pulse rate. The information is displayed on a liquid crystal display with pulse bar graph and audible pulse tone. The OxiPen utilizes a two-layer architecture in which the oximeter-specific functions are managed by a dedicated subsystem (ChipOx) and the monitor functions including power management, display, and user interface are controlled separately.

EnviteC Reusable SoftTip Y SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and infant patients in hospitals, hospital-type facilities, mobile, and home environments.

EnviteC's Reusable SoftTip Y sensors are a modification of EnviteC's Multi-Site Y SpO2 Sensors listed in K043463. The modification integrates the two Y-sensor housing tips into a single molded rubber tube which facilitates placement on a digit. This modification preserves in its entirety the original optical geometry and specifications of the predicate Y-sensors. Like the Multi-site Y SpO2 sensors, EnviteC's SoftTip Y SpO2 sensors consist of a connector and a duplex cable which divides at the distal end to the LED light source and light sensitive photodetector. The EnviteC SoftTip Y SpO2 Sensors comprise a family of oximeter sensors designed and validated for compatibility with the same oximeter monitor manufacturers as the Y-Sensors. A unique SoftTip Y sensor exists for each manufacturer series, and each SoftTip Y sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, CSI, etc.). Each sensor type includes the following unique features: - Connector pin-outs specific for the manufacturer type . - . Component specifications specific for the manufacture type Each sensor also specifies the manufacturer type with two compatibility statements: - One printed on or attached to the sensor . - . One on the instructions for use.

EnviteC Reusable Multi-site Y SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments. Not recommended for use on the ear. Prescription device.

The EnviteC Reusable Multi-site Y SpO2 Sensors are a family of oximeter sensors validated for compatibility with the predicate oximeter manufacturers listed above. EnviteC's Reusable Multi-site Y SpO₂ Sensors consist of a connector and a cable which divides at the distal end into two sensor housings. One housing contains a dual LED light source, and the other contains a light sensitive photodetector. The housings may be positioned on various sites including the finger, thumb, toe, or foot, and are affixed by a medical grade tape. A unique Y sensor exists for each manufacturer above, and each Y sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, CSI, etc.). Each sensor type includes the following unique features: - Connector pin-outs specific for the manufacturer type . - Component specifications specific for the manufacture type Each sensor also specifies the manufacturer type with two compatibility statements: - One printed on or attached to the sensor . - One on the instructions for use.

Continuous or spot monitoring of non-invasive arterial oxygen saturation.

Multicompatible EnviteC Disposable and Reusable Oximeter Sensor(s)