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510(k) Data Aggregation

    K Number
    K060524
    Device Name
    DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES
    Manufacturer
    DOLPHIN MEDICAL INC.
    Date Cleared
    2006-06-15

    (108 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOLPHIN MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.
    Device Description
    The Dolphin 2000™ Datex Compatible Oximetry Sensors are fully compatible disposable and re-usable replacement sensors for use with major brands af pulse oximeter monitors. They represent a design change to the existing Dolphin Aristo Datex Compatible Sensors and the Dolphin 2000 Nellcor Compatible Sensors. The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to predicate devices. The emitter and detector diodes are embedded in a laminate fo that is connected to the cable assembly. The sensors have an adhesive bandage backing that allows the sensor to be applied to the patient by wrapping it around a finger or toe (measurement site). Four sizes of disposable Dolphin 2000 Oximetry Sensors are available, which are indicated for use for adult, pediatric, infant and neonatal application sites. The Dolphin 2000 disposable sensors are provided non-sterile for single patient use. Disposable sensors are connected to the host oximeter through the use of an adapter cable. The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespinstyle clip that is placed on the end of a finger clip sensor consistes of the emitter and detector components mounted in opposing clip halves, maintained in mild compression by a spring hinge. The molded outer components house the optoelectric components within contoured pads that maintain contact with the patient's fingeoloolear windows within these pads permit the optical energy to pass through the finge for the measurements.
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    K Number
    K040380
    Device Name
    DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420
    Manufacturer
    DOLPHIN MEDICAL INC.
    Date Cleared
    2004-08-31

    (196 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOLPHIN MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dolphin ONE Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate. The Dolphin ONE Model 420 oximetry sensor is indicated for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate.
    Device Description
    The Dolphin ONE Forehead Oximetry Sensor is a reusable sensor for use with approved Dolphin ONE pulse oximeter monitors. The reusable forehead sensor is for use on the forehead and held in place with a disposable adhesive disc and headband. The emitter and detector are mounted in a sealed pouch (same materials as in the reusable Y sensor above) constructed in a flat cylindrical shape. The sensor is provided non-sterile.
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    K Number
    K033876
    Device Name
    DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422
    Manufacturer
    DOLPHIN MEDICAL INC.
    Date Cleared
    2004-03-11

    (87 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOLPHIN MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dolphin 2000™ Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.
    Device Description
    The Dolphin 2000™ Oximetry Sensors are fully compatible disposable and re-usable replacement sensors for use with major brands of pulse oximeter monitors. They are Nellcor and BCI Compatible Sensors. The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to predicate devices. The emitter and detector diodes are embedded in a laminate of tapes and development an adhesive bandage that is connected to the cable assombly. "The consortient by wrapping it around a finger backing that allows the sensor to be upplied to the End (Colphin 2000 Oximetry Sensors are of toe (measurement site). Tour sizes of aloposes, infant and neonatal application available, which are indicated for doc for duall, positive, mon-sterile for single patient use. The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespin-The re-usable Dolphil 2005 Finger Olip Oximony Consor consists of the style clip that is placed on the one on anyon one on anyon maintained in mild emitter and detector components mounted in opposing clip halves, mainter and consected emitter and delection components mounted in opposing only his house the optiolection in complession by a spring mings. The montain contact with the patient's finger. Clear components within contoured paids that the read to pass through the finger for the measurements. The Re-usable Y sensor is for use on the ear, finger, hand, or neonatal foot and held in The Re-usable 1 Sensor is for use on the sensor can also be used on the adult ear with the place with a disposable bandage. The concer or enounted in a sealed pouch (same ear clip accessory." The emitter and other cructed in a Y shape. All Dolphin sensors are provided non-sterile.
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    K Number
    K032947
    Device Name
    NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210
    Manufacturer
    DOLPHIN MEDICAL INC.
    Date Cleared
    2003-10-17

    (25 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOLPHIN MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.
    Device Description
    The Dolphin 2000 Y Oximetry Sensor is a fully compatible re-usable replacement sensor for use with Nellcor pulse oximeter monitors. The Re-usable Y sensor is for use on the ear, finger, hand, or neonatal foot and held in place with a disposable bandage. The sensor can also be used on the adult ear with the ear clip accessory. The emitter and detector are mounted in a sealed pouch (same material as in the re-usable clip sensor above) constructed in a Y shape. The sensor is provided non-sterile.
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    K Number
    K031465
    Device Name
    MODEL 2100 PULSE OXIMETER
    Manufacturer
    DOLPHIN MEDICAL INC.
    Date Cleared
    2003-10-10

    (155 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOLPHIN MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dolphin Medical 2100 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
    Device Description
    The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a portable stand-alone device, connecting cable, and oximetry sensor(s) to noninvasively calculate the functional oxygen saturation of (SpO2) and pulse rate for adult, pediatric and neonatal patients. arterial hemoqlobin The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpO2 value, the high and low SpO2 and pulse rate alarm limits, alarms, trends and status messages. It contains the electronic hardware and software that receives and calculates the signals from the LEDs within the sensor to determine the function of arterial hemoglobin (SpQz) and pulse rate, and provide for the connection to the connecting cable. The Dolphin Medical Pulse Oximeter Model 2100 is available in one configuration as a portable standalone oximeter that is 10 cm / 3.94 inches high, 27.5 cm / 10.83 inches wide, 25 cm / 9.84 inches deep and weighs about 4 kg / 8.8 lbs. The unit is powered either with a voltage input of 100-240 Vac, 50-60 Hz or with a sealed lead-acid battery with an operating time of approximately 4 hours based upon 2 Ampere hour battery (200mA OEM Module, 300mA System Module) and a charge time of about 4.5 hours to 80% capacity. The extension cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration drive to the oximetry sensor from the monitor receives the detector signal from the oximetry sensor. The extension cable is available in one configuration and is approximately 8 feet / 2.44m in length, and the sensor(s) are approximately 18 inches / 45.72 cm in length. The sensor(s) measure light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood. The oximetry sensor is available in either a disposable configuration, and with one configuration for the extension cable (8 feet).
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    K Number
    K030629
    Device Name
    DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER
    Manufacturer
    DOLPHIN MEDICAL INC.
    Date Cleared
    2003-09-04

    (189 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOLPHIN MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dolphin Medical 2150 Handheld Pulse Oximeter is indicated for use for spot checking and/or continuous noninvasive monitoring of fractional oxygen saturation of arterial hemoglobin, pulse rate, and patient temperature. The 2150 is for use with adult pediatric and neonatal patients in hospitals and hospital type facilities.
    Device Description
    The Dolphin Medical 2150 Pulse Oximeter consists of the Dolphin ONE™ OEM 701 Module technology, and works with existing Dolphin ONE extension cables, and oximetry sensors to non-invasively calculate the functional saturation of arterial hemoglobin (SpO2) and pulse rate. It also includes a thermistor port which accepts off the shelf approved YSI 400 series patient temperature sensors for the reading of patient temperature. It features an easy-to-read display that presents patient data and status information: an LCD (liquid crystal display) display that shows the SpO2, pulse rate values, patient temperature, and other messages as appropriate. A Dolphin ONE Extension Cable connects the sensor to the 2150. The cable is available in two configurations, three foot or eight in length. The oximeter can be operated off either an internal rechargeable battery or with use of a medical grade AC power supply which is fumished with the unit. The Dolphin Medical Model 2150 Pulse Oximeter will be used for continuous noninvasive monitoring and spot checking of SpO2, pulse rate, and patient temperature for adult, pediatric, infant and neonatal patients in hospital-type facilities. Typical acute-care uses are the Operating Room, Recovery Room and the Adult and Neonatal Intensive Care Units. The Dolphin Medical Model 2150 Pulse Oximeter and accessories will be used for adult, pediatric and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused. The user responsible for the operation of the Dolphin Medical Model 2150 will normally be a licensed clinical professional such as a physician, nurse, or respiratory therapist.
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    K Number
    K030952
    Device Name
    DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421
    Manufacturer
    DOLPHIN MEDICAL INC.
    Date Cleared
    2003-05-19

    (54 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOLPHIN MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.
    Device Description
    The Dolphin 2000 Oximetry Sensors are fully compatible disposable and re-usable replacement sensors for use with Nellcor pulse oximeter monitors. They represent a design change to the Dolphin 2000 BCI Compatible Sensors. The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to predicate devices. The emitter and detector diodes are embedded in a laminate of tapes that is connected to the cable assembly. The sensors have an adhesive bandage backing that allows the sensor to be applied to the patient by wrapping it around a finger or toe (measurement site). Four sizes of disposable Dolphin 2000 Oximetry Sensors are available, which are indicated for use for adult, pediatric, infant and neonatal application sites. The Dolphin 2000 disposable sensors are provided non-sterile for single patient use. The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespinstyle clip that is placed on the end of a finger. The finger clip sensor consists of the emitter and detector components mounted in opposing clip halves, maintained in mild compression by a spring hinge. The molded outer components house the optoelectric components within contoured pads that maintain contact with the patient's finger. Clear windows within these pads permit the optical energy to pass through the finger for the measurements. The Dolphin 2000 re-usable sensors are provided non-sterile.
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    K Number
    K024235
    Device Name
    DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER
    Manufacturer
    DOLPHIN MEDICAL INC.
    Date Cleared
    2003-03-17

    (84 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOLPHIN MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dolphin Medical 2100 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor).
    Device Description
    The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a portable stand-alone device, connecting cable, and oximetry sensor(s) to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric and neonatal patients.
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    K Number
    K014218
    Device Name
    OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'
    Manufacturer
    DOLPHIN MEDICAL INC.
    Date Cleared
    2002-11-07

    (321 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOLPHIN MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dolphin Medical Voyager Pulse Oximeter and Accessories are indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an oximetry sensor). The oximeter is indicated for use with a Pocket PC (with Windows CE Operating System).
    Device Description
    The Pocket PC based Dolphin Medical Voyager Pulse Oximeter and Accessories, is fully functional handheld device to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate through a Compact Flash (CF) Card. The Voyager consists of a CF card, and a connecting cable and is sold with the Dolphin ONE reusable and disposable sensors and the Dolphin Voyager Software as accessories. The user is required to load the Dolphin Voyager Software on a Pocket PC. The Voyager is intended for battery use only using the internal Pocket PC battery. The oximeter must not be used when connected to any other device, or when placed in the recharging cradle provided by the Pocket PC manufacturer. The Dolphin Voyager software will disable the oximetry function and display a message "Unit Charging - Do Not Use" when external power is detected. The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpO2 value, the high and low SpO2 and pulse rate trends and status messages. It contains the electronic hardware and software that receives and calculates the signals from the LEDs within the sensor to determine the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and provide for the connection to the connecting cable. The connecting cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration driver to the oximetry sensor from the the monitor receives the detector signal from the oximetry sensor. The sensor(s) measure light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood.
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    K Number
    K021959
    Device Name
    DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100
    Manufacturer
    DOLPHIN MEDICAL INC.
    Date Cleared
    2002-07-11

    (27 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOLPHIN MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dolphin Medical Stand-Alone Pulse Oximeter, Model No. 2100 and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO2 sensor).
    Device Description
    The Dolphin Medical Pulse Oximeter Model 2100 and Accessories is a portable stand-alone device, connecting cable, and oximetry sensor(s) to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric and neonatal patients. The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpOz value, the high and low SpO2 and pulse rate alarms, trends and status messages. It contains the electronic hardware and software that receives and calculates the signals from the LEDs within the sensor to determine the functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate, and provide for the connection to the connecting cable. The Dolphin Medical Pulse Oximeter Model 2100 is available in one configuration as a portable standalone oximeter that is 10 cm / 3.94 inches high, 27.5 cm / 10.83 inches wide, 25 cm / 9.84 inches deep and weighs about 4 kg / 8,8 lbs. The unit is powered either with a voltage input of 100-240 Vac. 50-60 Hz or with a sealed lead-acid battery with an operating time of approximately 4 hours based upon 2 Ampere hour battery (200mA OEM Module) and a charge time of about 4,5 hours to 80% capacity. The extension cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration drive to the oximetry sensor from the monitor receives the detector signal from the oximetry sensor. The extension cable is available in one configuration and is approximately 8 feet / 2.44m in length, and the sensor(s) are approximately 18 inches / 45.72 cm in lenath. The sensor(s) measure light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood, The oximetry sensor is available in either a disposable configuration, and with one configuration for the extension cable (8 feet).
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