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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
ST CARDIO TECHNOLOGIES, LLC
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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