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510(k) Data Aggregation
K Number
K102507Device Name
AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
Manufacturer
TZ MEDICAL, INC.
Date Cleared
2011-06-13
(285 days)
Product Code
DSI
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
TZ MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use by individuals who are at risk of having cardiac disease and those that have intermittent symptoms indicative of cardiac disease and demonstrated a need to be monitored on a continuing basis. The ECG recordings can be uploaded to monitoring center in a variety of ways - transmitted via Cellular RF Modem, via RF, via TTL, or flash card to an FTP storage location or software package to be read by a healthcare professional.
Patients include, but at are not limited to, those requiring monitoring for a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACS, PSVT) and ventricular ectopy, b) evaluation of bradyarrhthmias and intermittent bundle branch block including after cardiovascular surgery and myocardial infarction, and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
Patients with symptoms that may be due to cardiac arrhythmias. These may include, but are not limited to, symptoms such as a) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded, c) dyspnea (shortness of breath). Patients with palpitations with or without known arrhythmias to obtain correlation or arrhythmias with symptoms.
Patients who requiring monitoring of the effects of drugs to control ventricular rate in atrial arrhythmias (e.g. atrial fibrillation).
Patients recovery from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive central) to evaluate possible nocturnal arrhythmias.
Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or flutter.
Data from this device may be used by another device to analyze , measure or report QT interval . The device is not intended to sound any alarms for QT interval changes.
Device Description
The Aera CT is an ECG Device with auto trigger capability using MCOT compliant wireless technology for monitoring ambulatory patients with non-life threatening conditions.
The device is composed of patient (ECG) leads, monitor, and charging wall board adapter.
A sensor captures the ECG signal from the patient's body and transmits the signal to the small (hand sized) monitor where data is stored and analyzed by automated arrhythmia analysis algorithms. When events are detected by the arrhythmia analysis algorithm or when the event processing event key is depressed, the data is transmitted by RF to a data storage location monitored by receiving center. The transmission may occur via Cellular RF modem, RF, or TTL via a landline telephone. The data is received and reviewed by the appropriately trained healthcare professionals or technicians. Request for additional data can be sent to MCT device via SMS text formatted message that will originate from the receiving software.
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K Number
K062577Device Name
V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC
Manufacturer
TZ MEDICAL, INC.
Date Cleared
2006-12-15
(106 days)
Product Code
DSA
Regulation Number
870.2900Why did this record match?
Applicant Name (Manufacturer) :
TZ MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The V1 Multi-port Connector is intended to be used primarily in electrophysiology (EP) laboratories as a multi-port connector with switching capabilities for connection to defibrillator, EP study equipment and electrosurgical devices. It provides a stable, focal location for multiple wires, cables and connections. The device allows the defibrillator to be used as a back-up for stimulating and pacing when those pieces of equipment are unavailable.
Device Description
The V1 Multi-port Connector is intended to be used primarily in electrophysiology (EP) laboratories as a multi-port connector with switching capabilities for connection to defibrillator, EP study equipment and electrosurgical devices. It provides a stable, focal location for multiple wires, cables and connections. The device allows the defibrillator to be used as a back-up for stimulating and pacing when those pieces of equipment are unavailable.
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K Number
K040208Device Name
NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
Manufacturer
TZ MEDICAL, INC.
Date Cleared
2004-05-11
(102 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
TZ MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neptune Pad (calcium alginate pad alone): Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy.
Neptune Comfort-Band (Pressure Band with calcium alginate pad): Neptune Comfort-Band is used to provide pressure and promote the rapid control of bleeding and promote hemostasis following needle puncture, arterial/venous catheterization and access sites, including patients on anticoagulation therapy, and following hemodialysis.
Comfort-Band (Pressure Band alone): Comfort-Band is used to provide pressure and promote the rapid control of bleeding and hemostasis following needle puncture, arterial/venous catheterization and access sites, including patients on anticoagulation therapy, and following hemodialysis. It may be used alone, with Neptune Pad, with sterile gauze or other sterile wound dressings.
Device Description
Neptune Pad - Varying size, packaged sterile pads may be used alone as a wound dressing. The Pad may also be used with manual pressure or FDA cleared mechanical pressure devices to provide rapid control of bleeding and hemostasisat the skin surface.
Neptune Comfort-Band - The Comfort-Band is packaged with a Neptune Pad, and sterilized. It is strapped around the arm (hemodialysis graft, or radial/brachial arteries) to provide pressure for rapid control of bleeding and hemostasis.
Comfort-Band - The Comfort-Band is provided sterile or non-sterile, single use only. Non-sterile Comfort-Bands are provided with cleaning and high level disinfectant instructions) The Sterile Comfort-Band is packaged alone and EtO sterilized. The Comfort-Bands may be used with or without a dressing. The device is strapped around the arm (hemodialysis graft, or radial/brachial arteries) to provide rapid pressure control of bleeding and hemostasis.
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K Number
K021421Device Name
PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE
Manufacturer
TZ MEDICAL, INC.
Date Cleared
2003-04-18
(350 days)
Product Code
DRF
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
TZ MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The fixed PadTac electrophysiology mapping and recording catheters and PadTac cables are used for recording intracardiac electrogram (EGM) and for cardiac stimulation during diagnostic electrophysiology studies. The catheters will be used in the high right atrium, right ventricular apex and HIS bundle (recording only). The cables and box connect the catheter to the recording system.
Device Description
The PadTac Electrophysiology catheters are between 5 and 8 french (fr), 4, 10, 12 and 14 pole, fixed, monitoring and recording.
The multi-electrode electrophysiology catheters are used for electrophysiology electrocardiograph recording and cardiac stimulation during diagnostic procedures. The cables and box serve as an extension between the catheter and the pin block.
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K Number
K001634Device Name
CARDIOSENTRY EVENT MONITOR, MODEL 8470-01
Manufacturer
TZ MEDICAL, INC.
Date Cleared
2000-12-21
(209 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
TZ MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993205Device Name
BOOKER BOX, MODEL PAD 5010
Manufacturer
TZ MEDICAL, INC.
Date Cleared
2000-07-20
(300 days)
Product Code
LDD
Regulation Number
870.5300Why did this record match?
Applicant Name (Manufacturer) :
TZ MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Booker Box is passive connector, which allows connection to two defibrillators at a time to allow the physician to place a back up pair of electrodes. When the device is connected to two separate low energy defibrillators (using the adaptor/connectors compatible with the individual defibrillator) and disposable electrodes, energy from the defibrillator passes through the device to the external disposable electrodes. Should the physician need to the second set of electrodes are used as a back up in case the first pair configuration is unable to convert. The device also can be connected to a generic physiologic monitor recorder cable to allow unipolar recording using one of the back electrodes.
- 1. Provides simultaneous connection to two defibrillators, which allows placement of a set of backup electrodes
- Provides connection to generic physiologic monitor recorder cable for unipolar recording from 2. using a back electrode.
- Used in Hospitals/EP Laboratories
- 4. Used with manual defibrillators and has been tested with the following devices:
Hewlett Packard CodeMaster Hewlett Packard 7600, 7800 Zoll PD1200, PD1400, "M" Series Siemans 410 PhysioControl LifePak LP5, LP6, LP8, LP9, LP10 and LP 12
Device Description
The Booker Box is passive connector, which allows connection to two defibrillators at a time to allow the physician to place a back up pair of electrodes.
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K Number
K983196Device Name
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
Manufacturer
TZ MEDICAL, INC.
Date Cleared
1999-09-15
(369 days)
Product Code
DRO
Regulation Number
870.5550Why did this record match?
Applicant Name (Manufacturer) :
TZ MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TZ Medical adult disposable electrodes are used by trained professionals in hospitals, doctors offices and Emergency medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.
Device Description
PadTac Adult Defibrillate/Cardiovert/Pace Pad Fac Addit Dollahilator - TZ Medical Inc.
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K Number
K983232Device Name
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
Manufacturer
TZ MEDICAL, INC.
Date Cleared
1999-09-15
(366 days)
Product Code
DRO, DAT
Regulation Number
870.5550Why did this record match?
Applicant Name (Manufacturer) :
TZ MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PadTac Pediatric disposable electrodes are used by trained professionals in hospitals, doctors offices and Emergency Medical Services for pediatric low-energy defibrillation, cardioversion, pacing and monitoring.
Device Description
PadTac Pediatric Defibrillate/Cardiovert/Pace/Monitoring Electrodes
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K Number
K982228Device Name
FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25
Manufacturer
TZ MEDICAL, INC.
Date Cleared
1999-01-14
(203 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
TZ MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TZ Medical "FM Demodulator" (4 or 12 lead) is an interface between an event recorder and ECG machine which takes FM frequency received from a heart monitor and translates it back into an electronic signal which can then be read by an ECG machine to provide ECG traces. The device is used with ECG machines which do not have built in "translators".
Device Description
The TZ Medical "FM Demodulator" (4 or 12 lead) is an interface between an event recorder and ECG machine which takes FM frequency received from a heart monitor and translates it back into an electronic signal which can then be read by an ECG machine to provide ECG traces.
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K Number
K973132Device Name
EZ HOLD 1 LBS., EZ HOLD 2 LBS
Manufacturer
TZ MEDICAL, INC.
Date Cleared
1998-01-12
(144 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
TZ MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EZ Hold is a weighted (1.0 and 2.0 pound) stainless steel (304) device used to assist a vascular technician or RN to hold pressure on the femoral artery post-cardiac catheriterization.
Device Description
The EZ Hold is a weighted (1.0 and 2.0 pound) stainless steel (304) device used to assist a vascular technician or RN to hold pressure on the femoral artery post-cardiac catheriterization. Currently the technician uses either their hand or fingers to compress the artery or they use a mechanical clamp. The EZ Hold uses disks, as used with the mechanical clamps, but is held in place by the technician until hemostasis is obtained.
The EZ Hold is: 1) designed to reduce the risk for the RN of direct prolonged contact with body fluids (blood), and 2) alleviate bio-mechanical stress which occurs during traditional digital compression of the femoral artery post-cardiac catheritization. The devices work with currently marketed compatiblepressure disks (DisCo PNO-R or PNO-1 or equivalent bal and socket fit), fits the palm of the hand and is weighted to provide pressure at the site.
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