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510(k) Data Aggregation
K Number
K973663Device Name
PALJET-B
Manufacturer
GOLDEN GATE BIO-DEVICE
Date Cleared
1998-02-10
(138 days)
Product Code
DRX, NOV
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
GOLDEN GATE BIO-DEVICE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Paljet-B patient cable system is a reusable ECG suction electrode system. It is designed for diagnostic purposes and is compatible with all electrocardiographs on the U.S. market.
Device Description
The Paljet-B patient cable system is a reusable ECG suction electrode system. The entire electrode assembly was redesigned using some different materials (these materials never come in contact with the patient and are made of plastic) these provided for a more reliable electrode. Also a safer electrode because of the elimination of any sharp edges on the contact surfaces that came into contact with human skin. Changed from an AC power source to DC power source reduced the weight and eliminated the hanging arm configuration to enhance the portability aspects of the new device. Many changes were made in the mechanical aspects of the machine, however the basic operational aspect of the Paljet is unchanged from the Wavetracer.
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