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510(k) Data Aggregation

    K Number
    K133450
    Device Name
    AIRSTRIP REMOTE PATIENT MONITORING
    Manufacturer
    AIRSTRIP TECHNOLOGIES, LP
    Date Cleared
    2014-02-14

    (95 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRSTRIP TECHNOLOGIES, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirStrip RPM is software capable of displaying physiologic and other patient information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians. AirStrip RPM is intended to be used by clinicians for the following purposes: · By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital - · To view the near real-time waveforms remotely - · To remotely review other standard or critical near real-time patient data from the monitored system · To provide a request for remote consultation regarding a patient's waveform or other data The AirStrip RPM software can display the physiologic data captured by other medical devices: - · ECG Waveform - · Heart Rate Monitored - · Respiratory Rate - · Oxygen Saturation - · Intracranial Pressure - · Central Venous Pressure - · Pulmonary Capillary Wedge Pressure - Cardiac Index - · Cardiac Output - · Cerebral Perfusion Pressure - · Urine Output - · Urine/Stool Mix Output - · Systolic Blood Pressure Invasive - · Mean Arterial Pressure Invasive - · Diastolic Blood Pressure Invasive - · Systolic Blood Pressure Cuff - · Mean Arterial Pressure Cuff - Diastolic Blood Pressure Cuff - · Vasoactive Infusions - · Antiarrhythmics - · Sedation - · Paralvtics - · Laboratory Data including - Blood Gas - Chemistry - Hematology - Coagulation - · Allergies - · Medications
    Device Description
    AirStrip RPM is software capable of displaying physiologic and other patient information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians.
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    K Number
    K133394
    Device Name
    AIRSTRIP REMOTE PATIENT MONITORING
    Manufacturer
    AIRSTRIP TECHNOLOGIES, LP
    Date Cleared
    2014-02-06

    (93 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRSTRIP TECHNOLOGIES, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K131786
    Device Name
    AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
    Manufacturer
    AIRSTRIP TECHNOLOGIES, LP
    Date Cleared
    2013-07-03

    (15 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRSTRIP TECHNOLOGIES, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians. AirStrip RPM is intended to be used by clinicians for the following purposes: · By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital · To view the near real-time waveforms remotely · To remotely review other standard or critical near real-time patient data from the monitored system · To provide a request for remote consultation regarding a patient's waveform or other data The AirStrip RPM software can display the following the physiologic data captured by other medical devices: - · ECG Waveform - · Heart Rate Monitored - · Respiratory Rate - · Oxygen Saturation - · Intracranial Pressure - · Central Venous Pressure - · Pulmonary Capillary Wedge Pressure - · Cardiac Index - · Cardiac Output - · Cerebral Perfusion Pressure - · Urine Output - Urine/Stool Mix Output - · Systolic Blood Pressure Invasive - · Mean Arterial Pressure Invasive - · Diastolic Blood Pressure Invasive - · Systolic Blood Pressure Cuff - · Mean Arterial Pressure Cuff - · Diastolic Blood Pressure Cuff - - · Vasoactive Infusions · Antiarrhythmics - - · Sedation - · Paralytics - · Laboratory Data including - Blood Gas - Chemistry - Hematology - Coagulation - · Allergies - · Medications
    Device Description
    AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians.
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    K Number
    K122133
    Device Name
    AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
    Manufacturer
    AIRSTRIP TECHNOLOGIES, LP
    Date Cleared
    2012-10-02

    (76 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRSTRIP TECHNOLOGIES, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians. AirStrip RPM is intended to be used by clinicians for the following purposes: • By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital · To view the near real-time waveforms remotely · To remotely review other standard or critical near real-time patient data from the monitored system • To provide a request for remote consultation regarding a patient's waveform or other data The AirStrip RPM software can display the physiologic data captured by other medical devices: - · ECG Waveform - · Heart Rate Monitored - · Respiratory Rate - · Oxygen Saturation - · Intracranial Pressure - · Central Venous Pressure - · Pulmonary Capillary Wedge Pressure - Cardiac Index - · Cardiac Output - · Cerebral Perfusion Pressure - · Urine Output - · Urine/Stoo! Mix Output - · Systolic Blood Pressure Invasive - · Mean Arterial Pressure Invasive - · Diastolic Blood Pressure Invasive - · Systolic Blood Pressure Cuff - · Mean Arterial Pressure Cuff - · Diastolic Blood Pressure Cuff - · Vasoactive Infusions - Antiarrhythmics - Sedation - · Paralytics - · Laboratory Data including - Blood Gas - Chemistry - Hematology - Coaqulation - · Allergies - · Medications Counter-Indications Ocamer manageno intended for use anywhere cellular telephones or wireless devices are prohibited. AirStrip RPM is intended for use the hour when they cannot be at the hospital. AirStrip RPM is intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitoring devices from which it obtains its data.
    Device Description
    AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians.
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    K Number
    K121871
    Device Name
    AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
    Manufacturer
    AIRSTRIP TECHNOLOGIES, LP
    Date Cleared
    2012-07-03

    (6 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRSTRIP TECHNOLOGIES, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirStrip RPM is software capable of displaying physiologic and not by AirStrip RPM. AirStrip RPM. AirStrip RPM generated by other medical devices and patential and displays it for clinicians. AirStrip RPM is intended to be used by clinicians for the following purposes: • By using a cellular telephone or other device on which AirStrip RPM is installed, to review phy patient when the clinician is not at the hospital • To view the near real-time waveforms remotely • To remotely review other standard or critical near real-time payafam as ather deta • To remotely review other standard of entilour roar time patient's waveform or other data The AirStrip RPM software can display the following the physiologic data captured by other medical devices: • Heart Rate Monitored • Respiratory Rate • Oxygen Saturation • Intracranial Pressure • Central Venous Pressure • Pulmonary Capillary Wedge Pressure • Cardiac Index • Cardiac Output • Cerebral Perfusion Pressure • Urine Output • Urine/Stool Mix Output • Systolic Blood Pressure Invasive • Mean Arterial Pressure Invasive • Diastolic Blood Pressure Invasive • Systolic Blood Pressure Cuff • Mean Arterial Pressure Cuff • Diastolic Blood Pressure Cuff • Vasoactive Infusions • Antiarrhythmics • Sedation • Paralytics • Laboratory Data including - Blood Gas - Chemistry - Hematology - Coaqulation • Alleraies • Medications
    Device Description
    AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software
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    K Number
    K112235
    Device Name
    AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
    Manufacturer
    AIRSTRIP TECHNOLOGIES, LP
    Date Cleared
    2011-08-26

    (22 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRSTRIP TECHNOLOGIES, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirStrip RPM is software capable of displaying physiologic and other patient information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians. AirStrip RPM is intended to be used by clinicians for the following purposes: · By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital - · To view the near real-time waveforms remotely - · To remotely review other standard or critical near real-lime patient data from the monitored system - · To provide a request for remote consultation regarding a patient's waveform or other data The AirStrip RPM software can display the physiologic data captured by other medical devices: - · ECG Waveform - · Heart Rate Monitored - · Respiratory Rate - · Oxygen Saturation - · Intracranial Pressure - · Central Venous Pressure - · Pulmonary Capillary Wedge Pressure - Cardiac Index - · Cardiac Output - · Cerebral Perfusion Pressure - · Urine Output - · Urine/Stool Mix Output - · Systolic Blood Pressure Invasive - · Mean Arterial Pressure Invasive - · Diastolic Blood Pressure Invasive - · Systolic Blood Pressure Cuff - Mean Arterial Pressure Cuff - · Diastolic Blood Pressure Cuff - · Vasoactive Infusions - · Antiarrhvthmics - · Sedation - · Paralvtics - · Laboratory Data including - Blood Gas - Chemistry - Hematology - Coagulation - · Allergies - · Medications
    Device Description
    AirStrip RPM is software capable of displaying physiologic and other patient information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians.
    Ask a Question
    K Number
    K110503
    Device Name
    AIRSTRIP REMOTE PATIENT MONITORING (RPM)
    Manufacturer
    AIRSTRIP TECHNOLOGIES, LP
    Date Cleared
    2011-03-10

    (16 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRSTRIP TECHNOLOGIES, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians. AirStrip RPM is intended to be used by clinicians for the following purposes: • By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital - To view the near real-time waveforms remotely - To remotely review other standard or critical near real-time patient data from the monitored system - To provide a request for remote consultation regarding a patient's waveform or other data The AirStrip RPM software can display the physiologic data captured by other medical devices: - ECG Waveform - Heart Rate Monitored - Respiratory Rate - Oxygen Saturation - Intracranial Pressure - Central Venous Pressure - Pulmonary Capillary Wedge Pressure - Cardiac Index - Cardiac Output - Cerebral Perfusion Pressure - Urine Output - Urine/Stool Mix Output - Systolic Blood Pressure Invasive - Mean Arterial Pressure Invasive - Diastolic Blood Pressure Invasive - Systolic Blood Pressure Cuff - Mean Arterial Pressure Cuff - Diastolic Blood Pressure Cuff - Vasoactive Infusions - Antiarrhythmics - Sedation - Paralytics - Laboratory Data including - Blood Gas - Chemistry - Hematology - Coagulation - Allergies - Medications
    Device Description
    AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians.
    Ask a Question
    K Number
    K100133
    Device Name
    AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1
    Manufacturer
    AIRSTRIP TECHNOLOGIES, LP
    Date Cleared
    2010-07-23

    (185 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRSTRIP TECHNOLOGIES, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians. AirStrip RPM is intended to be used by clinicians for the following purposes: - By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital - To view the near real-time waveforms remotely - To remotely review other standard or critical near real-time patient data from the monitored system - To provide a request for remote consultation regarding a patient's waveform or other data The AirStrip RPM software can display the following the physiologic data captured by other medical devices: - ECG Waveform - Blood Pressure Waveform - 02 Waveform - CO2 Waveform - Heart Rate - Respiratory Rate - Oxygen Saturation - Intracranial Pressure - Central Venous Pressure - Pulmonary Capillary Wedge Pressure - Cardiac Index - Cardiac Output - Cerebral Perfusion Pressure - Urine Output - Urine/Stool Mix Output - Systolic Blood Pressure Invasive - Mean Arterial Pressure Invasive - Diastolic Blood Pressure Invasive - Systolic Blood Pressure Cuff - Mean Arterial Pressure Cuff - Diastolic Blood Pressure Cuff - Vasoactive Infusions - Antiarrhythmics - Sedation - Paralytics - Laboratory Data including - Blood Gas - Chemistry - Hematology - Coagulation - Allergies - Medications
    Device Description
    AirStrip RPM is software that runs on devices capable of running Apple iPhone OS. It interfaces with third-party centralized monitoring systems that in turn gather data from patient monitors and other devices in the hospital. AirStrip RPM gives health care providers the ability to view near-real-time patient physiological data remotely.
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    K Number
    K090269
    Device Name
    AIRSTRIP OB
    Manufacturer
    AIRSTRIP TECHNOLOGIES, LP
    Date Cleared
    2009-02-13

    (10 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRSTRIP TECHNOLOGIES, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirStrip OB® is intended to be used by Obstetricians for the following purposes: To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction patterns by viewing the real time waveforms remotely using a Windows-based handheld device To proactively review a fetal heart or maternal contraction tracing of a patient in Labor and Delivery for whom they are responsible but are unable to be present in the hospital at that time. To review the current Labor and Delivery patient census list. Provide a request for remote consultation regarding a fetal heart tracing. To remotely review other standard or critical real-time numeric data from Labor and Delivery.
    Device Description
    Not Found
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    K Number
    K090061
    Device Name
    AIRSTRIP OB
    Manufacturer
    AIRSTRIP TECHNOLOGIES, LP
    Date Cleared
    2009-01-23

    (14 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRSTRIP TECHNOLOGIES, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirStrip OB® is intended to be used by Obstetricians for the following purposes To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction patterns by viewing the real time waveforms remotely using a Windows-based handheld device To proactively review a fetal heart or maternal contraction tracing of a patient in Labor and Delivery for whom they are responsible but are unable to be present in the hospital at that time To review the current Labor and Delivery patient census list Provide a request for remote consultation regarding a fetal heart tracing To remotely review other standard or critical real-time numeric data from Labor and Delivery
    Device Description
    Not Found
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