FDA 510(k) Applications for Medical Device Product Code "ERA"
(Otoscope)

FDA 510(k) Number Applicant Device Name Decision Date
K123821 BLUE FOCUS AIO HD OTOSCOPE 05/17/2013
K121326 LANTOS TECHNOLOGIES LANTOS 3D EAR SCANNER 01/25/2013
K945264 OPTUS, INC. OPTUS OTOSCOPES 02/02/1996
K110326 OSRAM SYLVANIA, INC. OSRAM ITOS 10/27/2011


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