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510(k) Data Aggregation
K Number
K140644Device Name
PROCEM
Manufacturer
OTOTRONIX, LLC
Date Cleared
2014-06-19
(98 days)
Product Code
NEA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
OTOTRONIX, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ProCem™ is intended for non-weight bearing applications in Otologic surgery, such as:
1. Reconstruction of ossicular bones or mechanical coupling of the ossicular chain.
2. Mechanical stabilization of middle ear and cochlear implants.
3. Attachment of middle ear implants to the ossicular bones.
Device Description
ProCem™ is glass ionomer cement that is provided as two components, a glass powder and polyacrylic acid liquid. By mixing the two components, viscous moldable ionomeric cement is obtained which hardens in situ. ProCem™ is provided in a sterile capsule. The capsule includes the two separate components, a glass powder and polyacrylic acid liquid. An activator is used to release the liquid component prior to use. The capsule is then placed in a mixer, which mixes the glass powder and polyacrylic acid liquid to form a compliant cement. The applicator is used to apply the compliant cement to the appropriate location in the middle ear. The cement then hardens in place to provide a permanent bond.
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K Number
K130201Device Name
NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM
Manufacturer
OTOTRONIX, LLC
Date Cleared
2013-04-26
(88 days)
Product Code
GWN
Regulation Number
882.1460Why did this record match?
Applicant Name (Manufacturer) :
OTOTRONIX, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nystagram™ is a video nystagmograph intended to view, record, and measure eye movements in support of identification of balance disorders. The device is intended for use only by qualified, trained medical personnel to aid in diagnostic recommendations. This device does not provide any medical diagnosis and is intended to be part of a larger balance assessment battery.
Device Description
The Nystagram™ is a device that views, records and measures both vertical and horizontal eye movements for support of identification of balance disorders. The results of the video nystagmograph (VNG) tests are combined with other clinical information to allow qualified medical personnel to determine the health of a patient's vestibular function system. The Nystagram™ system consists of a goggles system with a video camera and accelerometers to record eye movements and head position, computer monitors and other hardware and software to control the operation of the patient stimulus and the test administration functions. The system software is used for nystagmus analysis during oculomotor mobility, positional nystagmus, and caloric examinations. The results are presented in visual diagrams for clinical review.
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