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510(k) Data Aggregation
K Number
K964522Device Name
ELLIPSE 4
Manufacturer
ANDROMEDA MEDIZINISCHE SYSTEME GMBH
Date Cleared
1997-03-21
(129 days)
Product Code
FEN, PAN
Regulation Number
876.1620Why did this record match?
Applicant Name (Manufacturer) :
ANDROMEDA MEDIZINISCHE SYSTEME GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ellipse 4™ is intended to assist in the diagnosis of incontinence and/or voiding disorders.
The Ellipse 4™ is a Urodynamic System. It can perform the following tests: Flowmetry, Cystometry, Pressure Flow, Urethral Pressure Profile and EMG.
Device Description
The Ellipse 4™ is a small, compact device that can register pressures, uroflow and EMG from the patient. The signals are AD converted and displayed on a LCD screen, printed on a thermal printer and stored in memory. After the recording, the data can be copied on a printer or downloaded to a PC using a network.
The Ellipse 4™ uses microp catheters (MTC's) for recording the pressures, and surface electrodes.
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