Address:4791 WEST 150TH ST.,CLEVELAND,OH,44135,US
Device Description : The Chroma model RZ153C Holter monitor is a battery operated solid-state recorde The Chroma model RZ153C Holter monitor is a battery operated solid-state recorder. It is designed for up to 48 hours (2 days) continuous recording of ambulatory electrocardiograph (AECG) data on a single AAA battery. It has the ability to detect and record pacemaker pulses according to the appropriate criteria for Association for the Advancement of Medical Instrumentation (AAMI) pacer detection.
Device Class : 2
Duns Number: 808204957
Premarket Exempt : No
Prescription Use : Yes
Device Class : 2
Duns Number: 808204957
Premarket Exempt : No
Prescription Use : Yes
Device Description : The TeleSense device is intended for diagnostic evaluation of patients who exper The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms orasymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records thedata, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, andautomatically transmits the recorded event activity associated with these symptoms for review by a licensedphysician.The TeleSense is a battery powered device to be used to measure, record, store and/or remotely transfer theElectrocardiogram (ECG) noninvasively in mobile patients. The available data transfer methods are USB and Wi-Fi.TeleSense is not limited to certain patient groups or pathologies; however, the TeleSense is not intended forpediatric use. Examples of applications are:- Cardiology- Pulmonary Care- Home Care- General PractitionersContraindications:a. Patients with potentially life-threatening arrhythmias who require inpatient monitoring.b. Patients who the attending physician thinks should be hospitalized.
Device Class : 2
Duns Number: 808204957
Premarket Exempt : No
Prescription Use : Yes
Device Description : The TeleSense device is intended for diagnostic evaluation of patients who exper The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms orasymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records thedata, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, andautomatically transmits the recorded event activity associated with these symptoms for review by a licensedphysician.The TeleSense is a battery powered device to be used to measure, record, store and/or remotely transfer theElectrocardiogram (ECG) noninvasively in mobile patients. The available data transfer methods are USB and Wi-Fi.TeleSense is not limited to certain patient groups or pathologies; however, the TeleSense is not intended forpediatric use. Examples of applications are:- Cardiology- Pulmonary Care- Home Care- General PractitionersContraindications:a. Patients with potentially life-threatening arrhythmias who require inpatient monitoring.b. Patients who the attending physician thinks should be hospitalized.
Device Class : 2
Duns Number: 808204957
Premarket Exempt : No
Prescription Use : Yes
Device Description : 3.7V Rechargeable Lithium Polymer battery for use in TeleSentry Devices
Device Class : 2
Duns Number: 808204957
Premarket Exempt : No
Prescription Use : Yes
Device Description : Cardiac Rehab ECG telemetry transmitter.
Device Class : 2
Duns Number: 808204957
Premarket Exempt : No
Prescription Use : Yes
Device Description : Cardiac Rehab ECG telemetry transmitter.
Device Class : 2
Duns Number: 808204957
Premarket Exempt : No
Prescription Use : Yes
Device Description : Cardiac Rehab 3 Lead patient cable used to connect to Angel and Innovo transmitters.
Device Class : 2
Duns Number: 808204957
Premarket Exempt : No
Prescription Use : Yes
Device Class : 2
Duns Number: 808204957
Premarket Exempt : No
Prescription Use : Yes
Device Description : 5 lead ECG patient cable to be used with the Chroma2 device.
Device Class : 2
Duns Number: 808204957
Premarket Exempt : No
Prescription Use : Yes