ClearanceBrief
510(k) K945689 ยท EWO Audiometer

GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM)

ApplicantCalmed Technology, Inc., Union City CA, US
DecisionSubstantially Equivalent, Feb 8, 1995
ReceivedNov 21, 1994
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K945689

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.