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510(k) Data Aggregation
K Number
K030407Device Name
ADVISOR, MODEL 9200
Manufacturer
BCI, INC.
Date Cleared
2003-08-19
(193 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
BCI, 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). Capnography (ETCO2, inCO2, RR), a two-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 neonate to adults when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status.
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.
Device Description
The BCI 9200 vital signs monitor has been updated to include a new capnography option. This new feature uses the same technology as existing legally marketed devices. This device is designed to provide full featured monitoring capabilities in a table top design. The full system features an ECG cable interface, two invasive pressure interfaces, two YSI 400/700 compatible temperature interfaces, an NIBP cuff hose connection, an SpO2 sensor interface, a capnography tubing interface and filters, an internal printer, display of patient and waveform data via a color liquid crystal display (LCD), system power status LEDs, a rotary control knob and the function keypad area consisting of five keys ( on/off, IP zero, NIBP start/stop, print start/stop and alarm silence). The monitor has analog and serial output ports that are used for data communications to personal computers, printers, chart recorders, or the Life Sensing Instrument Company, Inc. HTS 820 Central Station.
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K Number
K031742Device Name
BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER
Manufacturer
BCI, INC.
Date Cleared
2003-08-18
(75 days)
Product Code
DQA, DXN
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
BCI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 6004 NIBP monitor is a low cost 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 SpO3, optional oral/rectal temperature, and/or inter. The device will provide NIBP measurements on patients ranging from neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. An LED indicator illuminates when the monitor is configured for NIBP neonate mode. The BCI oximetry options work with all BCI oximetry sensors when providing SpO2 and pulse rate on all patients from neonate to adult in both NIBP adult and neonate mode. The Nellcor oximetry option provides SpO3 and pulse rate data on adult patients using the Nellcor DS 100A sensor. The electronic thermometry option is intended for intermittent "spot checks" of oral or rectal temperature for patients neonate through adult and requires WelchAllyn thermometry probes and probe covers. The temperature option works for all patients in NIBP adult or neonate mode. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use.
Device Description
The currently marketed BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional pulse oximeter, electronic thermometer and printer has been updated to include an additional Nellcor pulse oximeter option which uses the same technology as existing legally marketed devices. The BCI 6004 NIBP monitor with Nellcor pulse oximetry uses the Nellcor MP506 pulse oximetry module. This same module is used in the Nellcor Oximax N-550 Pulse Oximeter (K021090). The Nellcor MP506 board uses the same technology in a very similar design to that found in the Nellcor N-595 Pulse Oximeter.
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), 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
K020739Device Name
BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR
Manufacturer
BCI, INC.
Date Cleared
2002-06-03
(89 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
BCI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BCI® 3178 Pediatric Pulse Oximetry Sensor is a reusable finger sensor that can be used to non-invasively measure oxygen saturation (SpO2), pulse rate and wethysmographic pulse waves. It's performance was validated with the BCI® 3304 pulse oximeter. The BCT® 3178 Pediatric Pulse Oximetry Sensor will provide reliable spot check measurements on patients weighing from 10 to 100 lbs (5 -45 kg). The sensor is not intended for prolonged use.
Device Description
The BCI® 3178 pediatric pulse oximetry sensor is similar to other existing finger sensors, legally marketed by BCI, Inc. and others. This new finger sensor is designed to work with all BCI pulse oximeters on pediatric patients from 10 to 100 lbs. 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
K020350Device Name
BCI 3180 PULSE OXIMETER
Manufacturer
BCI, INC.
Date Cleared
2002-04-30
(85 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
BCI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BCI 3180 pulse oximeter is indicated for continuous patient monitoring of patient SpO2, pulse rate, and pulse strength measurements. It is intended for the hospital or clinical environment and during emergency land transport. It is intended for use in critical environments, including ventilatory applications, patient transport, and anesthesia. It is not intended for use in the home. The pulse oximeter is intended for use with all BCI pulse oximetry sensors, providing SpO2 and pulse rate measurements on all patients from neonate to adult.
Device Description
The BCI 3180 pulse oximeter is a new monitor with the same parameters as existing devices legally marketed by BCI, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system features an SpO2 sensor interface, display of patient and waveform data via an LCD display, power status LED, and the function keypad area consisting of six keys (on/off, waveform / trend, alarm audio pause/off, menu / enter, up arrow & down arrow). The monitor has an infrared serial port that is used for data communications to a printer and can download trend data to a printer of personal computer through connection to the SpQ2 sensor interface (sensor must be removed from the device).
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K Number
K013862Device Name
BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM
Manufacturer
BCI, INC.
Date Cleared
2002-02-21
(92 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
BCI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BCI 1621 Oximetry Data Management Program analyzes data recorded using the BCI 3403 pulse oximeter and provides a printed oximetry data analysis report and graphical SpO2 trend. This information can aid in the analysis of pulse oximetry data from sleep screening, oxygen therapy validation, and/or related studies. Data from the BCI 3403 pulse oximeter are downloaded for analysis using a unique cable.
Device Description
The BCI® 1621 Oximetry Data Management Program is a software program used as a pulse oximetry accessory.
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K Number
K013171Device Name
3420 DIGIT PULSE OXIMETER, MODEL 3420
Manufacturer
BCI, INC.
Date Cleared
2002-01-03
(101 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
BCI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BCI® 3420 Digit™ Pulse Oximeter is a handheld, finger-mounted pulse oximeter that combines the monitor and sensor into one assembly that measures SpO2, pulse rate, and pulse strength. It may be used as a spot check device in the home, hospital or clinical environments, including patient ground transport in clinical and EMS (Emergency Medical Services) settings. The BCI 3420 Digit™ Pulse Oximeter will provide reliable measurements on patients ranging from pediatric to adults.
Device Description
The BCI® 3420 Digit™ Pulse Oximeter consists of an pulse oximeter monitor and sensor contained on a single assembly. The device includes an LED display and power on key, and is powered by two "AAA" batteries.
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K Number
K011156Device Name
BCI 3403 SLEEP SCREENING PULSE OXIMETER
Manufacturer
BCI, INC.
Date Cleared
2001-06-14
(59 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
BCI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010770Device Name
BCI ADVISOR VITAL SIGNS MONITOR (9200)
Manufacturer
BCI, INC.
Date Cleared
2001-06-12
(90 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
BCI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011177Device Name
BCI ADVISOR VITAL SIGNS MONITOR (9200)
Manufacturer
BCI, INC.
Date Cleared
2001-05-23
(36 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
BCI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001770Device Name
BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A
Manufacturer
BCI, INC.
Date Cleared
2000-07-05
(23 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
BCI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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