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510(k) Data Aggregation
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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