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K Number
K123821Device Name
AIO HD OTOSCOPE
Manufacturer
BLUE FOCUS
Date Cleared
2013-05-17
(156 days)
Product Code
ERA
Regulation Number
874.4770Why did this record match?
Applicant Name (Manufacturer) :
BLUE FOCUS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AIO HD otoscope is used to provide images of the ear canal and tympanic membrane. The AIO HD otoscope can be used to allow a physician a clear and focused view of the ear canal or tympanic membrane on a computer or monitor screen.
Device Description
AIO camera system consists of the camera hand probe, main storage unit and otoscope tip. The camera hand probe dimensions are 45 mm (w) x 60 mm (l) x 151 mm (h). The main unit dimensions are 235 mm (w) x 225 mm (l) x 58 mm (h). The otoscope tip is carefully inserted into the external ear to view the ear canal and ear drum.
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