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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?
Applicant Name (Manufacturer) :
Fischer Medical
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
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?
Applicant Name (Manufacturer) :
FISCHER MEDICAL TECHNOLOGIES, INC
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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