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510(k) Data Aggregation
K Number
K101606Device Name
MICROMED PD-8K INSULATION DEFECT DETECTOR
Manufacturer
MCGAN TECHNOLOGY, LLC
Date Cleared
2010-10-01
(115 days)
Product Code
HFG
Regulation Number
884.4160Why did this record match?
Applicant Name (Manufacturer) :
MCGAN TECHNOLOGY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroMed PD-8K system is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation integrity of electrosurgical instruments.
Device Description
The MicroMed PD-8K system (MMPD-8K) is comprised of a reusable hand-held instrument probe, a detector or control/base unit, a ground wire and a high voltage wire in which the appropriate electrode (instrument probe) is control with and a fight vone in a mich in appropriate electrode housed at the end of the detector (control/base) unit The battery adaptor (recharger) is provided with the system for recharging the battery. The MicroMed PD-8K electrodes are reusable.
MicroMed PD-8K System includes:
- Detector (base unit)
- Battery with Charging adaptor
- Probe handle with 2m (6ft) lead-Red HV Wire
- 2m (6ft) lead ground wire with clamp-Green Wire
- Brush electrode 8mm (0.31inch) wide brass wires
- Ring Electrode with brass wires
- Carrying case
- Standard Operating Instruction manuals. CD With additional information.
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