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510(k) Data Aggregation
K Number
K081781Device Name
NUWAV
Manufacturer
LABORIE MEDICAL TECHNOLOGIES, CORP
Date Cleared
2008-07-09
(15 days)
Product Code
IYO, AND, OYN
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
LABORIE MEDICAL TECHNOLOGIES, CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NuWav Ultrasound Probe System is intended to used to perform diagnostic general ultrasound studies including Fetal, Abdominal (Solid Organs, Aneurysms, bladder), Pediatric, Small organ (breast, thyroid, bladder, testes, prostate), Neonatal Cephalic, Cardiac, Trans-vaginal, Trans-rectal, Peripheral Vascular, and Musculoskeletal (Conventional and Superficial). The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures as well as performing Urodynamic Studies.
Device Description
Not Found
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K Number
K073552Device Name
LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
Manufacturer
LABORIE MEDICAL TECHNOLOGIES, CORP
Date Cleared
2008-03-05
(78 days)
Product Code
FEN
Regulation Number
876.1620Why did this record match?
Applicant Name (Manufacturer) :
LABORIE MEDICAL TECHNOLOGIES, CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Laborie Urodynamic systems are intended for Urodynamics testing. The traditional equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The accessory to our standard equipment, Tetra, uses near infrared spectroscopy, for non-invasive testing of bladder activity, aiding in the diagnosis of patients with lower urinary tract symptoms - that is patients who suffer from Urinary Incontinence.
All Urodynamic equipment including the Laborie Urodynamic System with Tetra Accessory are for use under the direction of a licensed physical or health care professional in an office or hospital setting.
Device Description
The complete device includes traditional Urodynamic system and the Tetra accessory. That is all the standard components, for uroflowmetry and pressure measurement, and the new non-invasive component the Tetra accessory to detect bladder activity.
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