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510(k) Data Aggregation

    K Number
    K991086
    Device Name
    CAPNOCHECK II, MODEL 8400
    Manufacturer
    BCI INTL., INC.
    Date Cleared
    1999-06-09

    (70 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BCI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 8400 Capnocheck II is a low cost CO2 monitor with pulse oximeter and optional external printer. It may be used in the hospital or clinical environment, and during emergency land transport. It is not intended for use in the home. It is intended to be used in all critical environments, including ventilatory applications, patient ground transport, EMS (Emergency Medical Services) and anesthesia. The capnography parameter provides end tidal CO2 (ETCO2), inspired CO2 (inCO2), and respiration rate measurements on all patients from pediatric to adult. The oximetry parameter works with all BCI oximetry sensors, providing %SpO2 and pulse rate on all patients from pediatric to adult. The 8400 Capnocheck II permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals. It is not intended nor designed to be used as an apnea monitor.
    Device Description
    The BCI 8400 Capnocheck II monitor performs capnography and pulse oximetry using the same technology as existing legally marketed devices. Capnography data includes end-tidal CO2 (ETCO2), inspired CO2 (inCO2), and respiration rate measurements as well as a respiration breath indicator and ETCO2 waveform. Oximetry data includes functional arterial blood oxygen saturation (%SpO2) and heart rate measurements as well as pulse strength indicator and plethysmogram. This device is designed to provide full-featured monitoring. capabilities in a lightweight, hand-held design. The system consists of a small hand held monitor with optional infrared linked printer and AC powered battery eliminator. Features include a gas inlet connection, an exhaust gas connection, an SpO2 sensor interface, Ilquid crystal display (LCD), system status LEDs, function keypad, and infrared serial port. The LCD display has an electroluminescent (EL) backlight and displays patient data, waveforms, trends, breath and pulse rate indicators, alarm limit indicators, and messages. The keypad consists of six keys: power, waveform/trend, alarm silence, up and down arrows, and menu/enter. There are three system status LEDs: alarm silence, high and medium/low priority alarms. The infrared serial port is used for data communication with the optional printer.
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    K Number
    K991410
    Device Name
    3402 HANDHELD PULSE OXIMETER
    Manufacturer
    BCI INTL., INC.
    Date Cleared
    1999-06-09

    (48 days)

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

    BCI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3402 Digital Handheld Oximeter is a handheld, low cost pulse oximeter for spot checking or continuous monitoring of SpO2, pulse rate, and pulse strength. It may be used in all critical environments, including clinical and EMS (Emergency Medical Services), patient ground transport, and for use in sleep screening or in the home. The oximetry parameter works with all BCI oximetry sensors, providing SpO2 and pulse rate on all patients from neonate to adult. The 3402 Digital Handheld Oximeter permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals. The BCI 3402 is not designed or intended to be used as an apnea monitor.
    Device Description
    The BCI 3402 Digital Handheld Oximeter monitor is an updated version of an existing pulse oximeter legally marketed by BCI International. The system consists of an oximeter sensor interface, LED display, front and side keypads, and an infra-red LED printer output port. The device is powered by six "AA" batteries.
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    K Number
    K984618
    Device Name
    BCI MINI-TORR PLUS, MODEL 6004
    Manufacturer
    BCI INTL., INC.
    Date Cleared
    1999-03-25

    (86 days)

    Product Code
    DXN, DEC
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    BCI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BCI Mini-Torr Plus monitor is a portable noninvasive blood pressure (NIBP) monitor for spot checking or monitoring of a patient's systolic, diastolic, and mean arterial (MAP) blood pressures, and pulse rate. Optional oximeter, electronic thermometer and/or integral printer are available. The device will provide fast, reliable NIBP measurements on patients ranging form neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. The oximetry option works with all BCI oximetry probes, providing SpO2 and pulse rate on all patients from neonate to adult. The electronic thermometry option requires Welch Allyn thermometry probes and probe covers, and provides oral or rectal temperature information for neonate through adult patients. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals for the NIBP and oximetry functions.
    Device Description
    The BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional oximeter, electronic thermometer, and printer has been updated to include a new neonatal NIBP mode which uses the same technology as existing legally marketed devices. This device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top NIBP monitor with a desk top charger. Features include an NIBP cuff hose connection, an optional SpO2 sensor interface, an optional temperature probe interface and holder, an optional internal printer, display of patient data via an LED display (systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature), display of patient NIBP mode via an LED, system status LEDs (battery, sensor, alarm silence, alarm, and alert), and the function keypad area consisting of eleven keys (power, start, cancel, stat, up and down arrows, interval, recall, manual/auto, alarm set, and alarm silence). The monitor has a serial port that is used for data communication.
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    K Number
    K983796
    Device Name
    6004 NIBP MONITOR WITH TEMPERATURE
    Manufacturer
    BCI INTL., INC.
    Date Cleared
    1999-01-22

    (87 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    BCI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BCI Mini-Torr Plus monitor is a portable noninvasive blood pressure (NIBP) monitor for spot checking or monitoring of a patient's systolic, diastolic, and mean arterial (MAP) blood pressures, and pulse rate. Optional oximeter electronic thermometer and/or integral printer are available. The device will provide fast, reliable NIBP measurements on patients ranging from children (pediatric) to adults when using the appropriate BCI blood pressure cuff. The oximetry option works with all BCI oximetry probes, providing SpO2 and pulse rate on all patients from neonate to adult. The electronic thermometry option requires Welch Allyn thermometry probes and probe covers and provides oral or rectal temperature information for patients neonate through adult. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals for the NIBP and oximetry functions.
    Device Description
    The currently marketed BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional oximeter, and printer has been updated to include an additional electronic thermometer option which uses the same technology as existing legally marketed devices. This device is designed to provide full-featured monitoring capabilities in a lightweight, transportable design. The system consists of a small tabletop NIBP monitor with a desktop charger. Features include an NIBP cuff hose connection, an optional SpO2 sensor interface, an optional temperature probe interface and holder, an optional internal printer, display of patient data via an LED display (systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature), system status LEDs (battery, sensor, alarm silence, alarm, and alert), and the function keypad area consisting of eleven keys (power, start, cancel, stat, up and down arrows, interval, recall, manual/auto, alarm set, and alarm silence). The monitor has a serial port that is used for data communication.
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    K Number
    K982279
    Device Name
    VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200
    Manufacturer
    BCI INTL., INC.
    Date Cleared
    1998-09-25

    (87 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    BCI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead / 5 lead), impedance respiration (RSP), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and P2), and two temperature channels (T1 and T2). A 2-inch internal, graphical/alphanumeric printer and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from children (pediatric) to adults when using the appropriate BCI accessories. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor. The monitor is not intended for neonatal use.
    Device Description
    The BCI 9200 Vital Signs Monitor is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a table top design. The system features an ECG cable interface, two invasive pressure interfaces, two YSI compatible temparature interfaces, an NBP cuff hose connection, an SpO2 probe interface, the optional internal printer, display of patient and waveform data via a color LCD, system power status LEDs, a rotary control knob and the function keypad area consisting of five keys ( on/off, zero (IP zero), NIBP start/stop, print start/stop & alarm silence). The monitor has a serial port that is used for data communications.
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    K Number
    K981939
    Device Name
    AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR
    Manufacturer
    BCI INTL., INC.
    Date Cleared
    1998-08-20

    (79 days)

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

    BCI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BCI 3404 Monitor is a portable ECG and oximetry monitor with optional impedance respiration. It continuously and non-invasively monitors and displays functional oxygen saturation of arterial hemoglobin(SpO2), pulse rate, respiration rate, plethysmogram and ECG waveforms. Alarms are available for ECG and oximetry. There are no respiration rate alarms. The 3404 may be used in the hospital or clinical environment, and during emergency land transport. The device will provide fast, reliable measurements on patients ranging from pediatric to adult when using the appropriate BCI accessories. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor. The monitor is not intended for neonatal use.
    Device Description
    The BCI 3404 Oximeter / ECG Monitor is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a table top design. The system features an ECG cable interface, an SpO2 probe interface, display of patient and waveform data via an EL panel, power status LED, and the function keypad area consisting of six keys ( on/off, waveform / trend, alarm silence, up arrow & down arrow). The monitor has a serial port that is used for data communications to a printer or computer and for analog outputs.
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    K Number
    K980714
    Device Name
    BCI 3401 HANDHELD PULSE OXIMETER
    Manufacturer
    BCI INTL., INC.
    Date Cleared
    1998-03-25

    (29 days)

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

    BCI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BCI 3401 Pulse Oximeter is a handheld, low cost monitor for spot checking or attended monitoring of SpO2, pulse rate and pulse strength. The 3401 is a battery powered pulse oximeter with an optional built-in printer. It may be used in the hospital or clinical environment, and during emergency land transport. The oximeter will operate accurately over an ambient temperature range of 32 to 131°F (0 to 55°C). The oximeter works with all BCI oximetry sensors providing SpO2 and pulse rate on all patients from neonate to adult. This device is not intended for continuous patient monitoring. There are no audible or visable patient alarms. The device is not intended for home use.
    Device Description
    The BCI 3401 Handheld Pulse Oximeter is an updated version of an existing pulse oximeter legally marketed by BCI International. The system consists of two major elements. The first is the oximeter featuring the oximeter sensor interface, the LED display, and the keypad. The second element is the optional internal printer. The device is powered by four "AA" batteries.
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    K Number
    K974697
    Device Name
    REUSABLE FINGER SENSOR 3444
    Manufacturer
    BCI INTL., INC.
    Date Cleared
    1998-03-11

    (85 days)

    Product Code
    DQH
    Regulation Number
    870.2310
    Why did this record match?
    Applicant Name (Manufacturer) :

    BCI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3444 Reusable Finger Sensor is used with BCI oximetry to noninvasively measure oxygen saturation (SpOz), pulse rate and plethysmographic pulse waves. The 3444 sensor is recommended for patients weighing more than 15 kg and patients with limited activity. The 3444 Reusable Finger Sensor is not recommended for prolonged use unless skin integrity is checked frequently and the measurement site is changed accordingly. The Reusable Finger Sensor is for use with BCI International monitors and with monitors that contain BCI International oximelry or are licensed to use BCI International sensors.
    Device Description
    The BCI 3444 Reusable Oximetry Finger Sensor is an updated version of an existing finger sensor, the 3044, legally marketed by BCI International. This updated finger sensor is designed to work with all BCI oximeters. The sensor is made up of three major parts, the cable with the molded connector, the top part of the shell containing the LEDs and the bottom part of the shell containing the photo detector.
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    K Number
    K970801
    Device Name
    BCI MODEL 6004 NIBP MONITOR (6004)
    Manufacturer
    BCI INTL., INC.
    Date Cleared
    1997-11-12

    (253 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    BCI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 6004 NIBP monitor is a portable NIBP monitor for spot checking or monitoring of a patient's systolic, diastolic and mean arterial (MAP) blood pressures, and pulse rate, with optional SpO2 and/or integral printer. The device will provide fast, reliable measurements on patients ranging from children (pediatric) to adults when using the appropriate BCI blood pressure cuff. The oximetry option works with all BCI oximetry probes, providing SpO2 and pulse rate on all patients from neonate to adult. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
    Device Description
    The BCI 6004 NIBP monitor with optional pulse oximetry (SpO2) and printer is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top non-invasive blood pressure monitor with a desk top charger. The system features an NIBP cuff hose connection, an SpO2 probe interface, the optional internal printer, display of patient data via an LED display (Systolic, Diastolic, & Mean arterial pressure, Interval timer, SpO2, Pulse Rate, Pulse Strength), system status LEDs (Battery, Probe, Alarm Silence, Alarm, & Alert), and the function keypad area consisting of eleven keys (O/I (off/on), START, CANCEL, STAT, Up and Down Arrows, INTRVL, RECALL, MANUAL/AUTO, ALARM SET, & Alarm Silence). The monitor has a serial port that is used for data communication. The model 6004 has two parameters, NIBP and SpO2 plus the integrated printer.
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    K Number
    K970209
    Device Name
    CAPNOCHECK PLUS
    Manufacturer
    BCI INTL., INC.
    Date Cleared
    1997-04-18

    (87 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BCI INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 9004 may be used in the hospital or clinical environment, and during emergency land transport. It is not intended for use in the home. It is intended to be used in all critical environments, including ventilatory applications, patient transport and anesthesia environments. The oximetry ootion works with all BCI oximetry probes providing SpO2 and pulse rate. The patient population is defined to be pediatric to adults. The 9004 permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. It is not intended or designed to be used as an apnea monitor. The 9004 will operate accurately over an ambient temperature range of 32 to 122° F (0 to 50° C).
    Device Description
    The BCI Capnocheck Plus capnograph with optional pulse oximetry (SpO2) and fractional inspired oxygen (FiO2) is an updated version of existing devices legally marketed by BCI International. This updated device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top capnograph with a wall mount charger. The system features a gas inlet port with moisture trap for the breath sample (sidestream capnograph), an SpO2 probe interface, the FiO2 sensor connector, display of patient data via a VFD display (CO2, SpO2, Pulse Rate, Pulse Strength, FiO2, alarm information), system status LEDs (Battery, Alarm Silence, Alarm, & Alert), and the function keypad area consisting of six keys (STNBY/ON, WAVE/TREND, Up and Down Arrows, MENU/ENTER, & Alarm Silence). The capnograph has a serial printer / pc port that is used for data communication. Three analog output channels are supported on the same connector.
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