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Found 9 results
510(k) Data Aggregation
K Number
K173439Device Name
Bloom2 Programmable Electrophysiology Stimulator
Manufacturer
Fischer Medical
Date Cleared
2018-03-29
(146 days)
Product Code
JOQ
Regulation Number
870.1750Why did this record match?
Product Code :
JOQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bloom2 is intended for use in the electrophysiology laboratory during electrophysiology testing, under the direction of qualified personnel trained to administer electrophysiology procedures. The Bloom2 Cardiac Stimulator System is a programmable, electrical, pulse generator intended to provide diagnostic, electrical, cardiac stimulation. It is not intended for use, nor should it be used, as an external pacemaker for long-term support of the pacemaker dependent patient.
Device Description
The Bloom2™ Cardiac Stimulator System (Bloom²) is a programmable pulse generator used for electrophysiological testing of the human heart. The Bloom² has three main components, the Bloom2 Console, the Bloom2 Stimulator Unit and the Bloom2 Increment / Decrement Floater. The Console and the Floater contain the main user controls of the system. The Console consists of a touch screen and will allow the operator to setup the functions and parameters of the system. The user interface of the Console is based on the proven and familiar interface of the Bloom DTU-215B. The Floater provides additional user controls and will provide the operator with tactile feedback on those functions that the user is expected to use while going through their protocols. The Stimulator is the heart and brains of the system. The Stimulator has four, independent output channels that have a direct connection to the patient through third party catheters.
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K Number
K092913Device Name
EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04
Manufacturer
EP MEDSYSTEMS
Date Cleared
2009-10-16
(24 days)
Product Code
JOQ
Regulation Number
870.1750Why did this record match?
Product Code :
JOQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EP-4 Cardiac Stimulator is indicated for use during clinical cardiac electrophysiology procedures. The EP-4 Cardiac Stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhythmias, and measurements of electrical conduction.
Device Description
The EP-4 Cardiac Stimulator consists of a touch-screen computer, an AC-powered stimulation module, which provides electrical stimulation to the heart during electrophysiology case studies. The EP-4 consists of a touch-screen computer that controls a two- or four-channel AC-powered stimulation module, and a keyboard. The stimulator is capable of performing single channel, simultaneous, or sequential stimulation at programmed output settings using existing/predicate programmed protocols. The device is independent and self-contained, with the exception of marker outputs and an external sync input connector. It can be configured as a stand-alone system or in conjunction with the EP-WorkMate™ Recording System. It may also be used with other EP recording systems.
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K Number
K072200Device Name
STIMLAB
Manufacturer
MICROPACE PTY. LTD.
Date Cleared
2007-10-26
(79 days)
Product Code
JOQ
Regulation Number
870.1750Why did this record match?
Product Code :
JOQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StimLab Cardiac stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of initiation and termination of tachyarrhythmias, refractory measurements and measurements of electrical conduction.
Device Description
The StimLab™ is an EPS320 cardiac stimulator modified by the addition of a remote bedside touch monitor. The system consists of a manually controllable pulse generator issuing standard cardiac pacing pulses, normally controlled by a separate computer containing a graphic touch user interface and pre-programmed complex stimulation patterns suited to electrophysiology (EP) studies. In the StimLab™, a second remotely locatable beside control touch screen duplicates the video display and touch controls allowing verification and control of stimulator settings from two locations, one typically located in an electrophysiology laboratory central control room and the second at the operating table. The device is not a life support device and makes no diagnoses.
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K Number
K070743Device Name
Z6 STIMULATOR
Manufacturer
ST CARDIO TECHNOLOGIES, LLC
Date Cleared
2007-07-02
(108 days)
Product Code
JOQ
Regulation Number
870.1750Why did this record match?
Product Code :
JOQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Z6 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation electrophysiological testing of the human heart.
Device Description
The Z6 Stimulator is a cardiac pulse generator designed for use in an Electrophysiology Laboratory during electrophysiological studies. The system operates in conjunction with ECC Recording devices to deliver electrical stimulus to the patient's heart through up to four simultaneously operable output channels. The Z6 Stimulator is controlled by a CPU based Workstation with Windows XP. This provides programmability and flexibility with regard to the stimulus program and allows access to system users. Additionally, the system features a graphical interface with a Windows XP look and feel.
Each of the four independent output channels of the Z6 Stimulator is capable of generating between 0.1 and 25 mAs of current to the patient, with voltages up to 20 Volts. The System is capable of delivering pulses on all channels simultaneously. The duration of the pulses can be programmed to be between 0.5 and 10 ms, maintaining timing accuracy (> +/- 0.15 ms).
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K Number
K041442Device Name
EP-4 CLINICAL STIMUTATOR
Manufacturer
EP MEDSYSTEMS
Date Cleared
2004-09-14
(105 days)
Product Code
JOQ
Regulation Number
870.1750Why did this record match?
Product Code :
JOQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions.
Device Description
Not Found
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K Number
K040207Device Name
EP-4 CLINICAL STIMULATOR
Manufacturer
EP MEDSYSTEMS
Date Cleared
2004-02-27
(28 days)
Product Code
JOQ, 74J
Regulation Number
870.1750Why did this record match?
Product Code :
JOQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions,
Device Description
Not Found
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K Number
K011826Device Name
EPS320 CARDIAC STIMULATOR
Manufacturer
MICROPACE PTY. LTD.
Date Cleared
2002-01-24
(227 days)
Product Code
JOQ
Regulation Number
870.1750Why did this record match?
Product Code :
JOQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EPS320 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation during electrophysiological testing of the human heart.
Device Description
The Micropace EPS320 Cardiac Stimulator (Clinical Stimulator) is an external programmable computerised diagnostic cardiac stimulator. It is used in specialised hospital electrophysiological diagnostic laboratories by specialist cardiologists to electrically stimulate the heart to initiate and terminate tachyarrhythmias and allow measurement of refractory and conduction properties of the heart by third party equipment. The EPS320 system consists of a Stimulus Generator Unit (SGU) comprising of a manufactured metal instrument case and a standard IBM clone type Personal Computer (PC), the two interconnected by a serial data connection. The device has two independent fully programmable and isolated constant current pulse generator channels intended for temporary programmacro and locativa third party transvenous intracardiac electrodes. The pacing stimulus is output via a Stimulus Connection Box and may typically be routed to the intravenous pacing electrodes via third party electronic switching equipment. During normal operation of the EPS320, custom software on the PC provides keyboard input device and a graphical user interface which the operator uses to control the stimulation process in real time. The custom PC software interprets the user instructions and sends specific real-time commands to the I he ousehi I O software and and to control its function and generate appropriate pacing stimulus pulses. The two isolated outputs can deliver stimulus pulse widths from 0.5ms to 10ms, adjustable in 0.5 to 1ms steps with current amplitudes adjustable from 0.1mA to 25mA in steps of 0.1mA. Current delivery is limited within the specified range by a maximum available output voltage of 26V. The EPS320 is not a life support device and may be used only in the presence of a backup cardiac THE LE SES IS .In case of failure of mains power supply, malfunction of the PC or its software, or loss of the data link, the SGU can operate independently of the PC in the Manual Backup mode, powered by an internal backup battery. This operational mode can provides regular pacing stimuli at intervals and pulse current amplitudes programmable from and displayed on the SGU's front panel. It may be used to briefly support a bradycardic patient until temporary external pacing is established using an approved temporary pacemaker. A secondary electrically self-contained Emergency Fixed Pace approved willing the front of the SGU may be used for the same purpose in case of loss of normal SGU function.
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K Number
K991293Device Name
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR
Manufacturer
FISCHER MEDICAL TECHNOLOGIES, INC.
Date Cleared
2000-05-05
(386 days)
Product Code
JOQ
Regulation Number
870.1750Why did this record match?
Product Code :
JOQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DTU-215 Programmable Electrophysiology Stimulator with the EPStim Electrophysiology Stimulator Control Program is indicated for patients that are candidates for electrophysiology studies for the diagnosis, and the planning of treatment of supraventricular and other miscellaneous arrhythmias.
The EPstim is intended for assisting a physician in performing an electrophysiology study by providing automated control of the DTU-215 Programmable Stimulator. The system provides for compilation, storage and rapid execution of a customized series of stimulator outputs and provides for automated detection of capture during cardiac electrophysiological testing.
The DTU-215 Programmable Stimulator is intended for use in the electrophysiology laboratory setting under the direction of qualified personnel trained to administer electrophysiological procedures.
Device Description
EPStim Software and Bloom DTU Electrophysiology Program Stimulator
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K Number
K963579Device Name
PACE-1A CARDIAC STIMULATOR
Manufacturer
RADIONICS, INC.
Date Cleared
1996-11-08
(63 days)
Product Code
JOQ
Regulation Number
870.1750Why did this record match?
Product Code :
JOQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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