ClearanceBrief
510(k) K093495 ยท HLJ Ophthalmoscope, Battery-Powered

OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS

ApplicantAmerican Diagnostic Corp., Hauppauge NY, US
DecisionSubstantially Equivalent, Nov 19, 2010
ReceivedNov 10, 2009
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K093495

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.