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510(k) Data Aggregation
K Number
K960503Device Name
DANTEC DUET
Manufacturer
DANTEC MEDICAL, INC.
Date Cleared
1996-09-16
(227 days)
Product Code
FEN
Regulation Number
876.1620Why did this record match?
Applicant Name (Manufacturer) :
DANTEC MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dantec Duet™ system is intended for urodynamics testing. The Duet™ system is intended to assist practitioners in executing specific urodynamics test protocols, collecting data during protocol execution, analyzing collected data, preparing written reports and archiving patient and testing information.
General indications for use include use in patients with lower urinary tract voiding or continence problems, and more specifically incontinent patients, patients with bladder outlet obstructions, patients with neurogenic bladder dysfunction and some children with complex voiding / incontinence problems.
Device Description
The Dantec Duet™ is a computerized urodynamics measurement system. The system consists of a mobile cart or "trolley" with the following components mounted on it: a 486 based computer, color monitor, printer, dedicated keyboard, digital and analog measurement electronics, Windows™ based application software, transducers for measuring EMG, pressure, flow and weight, infusion stand, puller with arm, CO₂ gas pump, water pump, patient interface module and patient connecting accessories.
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K Number
K950314Device Name
DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
Manufacturer
DANTEC MEDICAL, INC.
Date Cleared
1996-03-25
(424 days)
Product Code
GXZ
Regulation Number
882.1350Why did this record match?
Applicant Name (Manufacturer) :
DANTEC MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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