510(k) Report

FDA applicant

Idem (Int'L Dist. of Electronics For Medicine)

Benicia, CA6 decisions1998–19990 recalls

FDA records 6 decisions for Idem (Int'L Dist. of Electronics For Medicine) (Benicia, CA) from 1998 to 1999: 6 510(k) clearances. Most are in product codes ETY (Tester, Auditory Impedance) and EWO (Audiometer). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Idem (Int'L Dist. of Electronics For Medicine)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Idem (Int'L Dist. of Electronics For Medicine) since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Idem (Int'L Dist. of Electronics For Medicine) by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ETYTester, Auditory Impedance3decisions
  • EWOAudiometer2decisions
  • GWJStimulator, Auditory, Evoked Response1decision

What has FDA decided for it lately?

  • K991853Interacoustics EP 15 Abr Stand Alone UnitIdem (Int'L Dist. of Electronics For Medicine) · 1999
  • K990585Interacoustics AT22T Automatic Impedance AudiometerIdem (Int'L Dist. of Electronics For Medicine) · 1999
  • K990652Interacoustics Model AZ26 Clinical Impedance AudiometerIdem (Int'L Dist. of Electronics For Medicine) · 1999
  • K983832Interacoustics Model MT 10, Handheld Impedance AudiometerIdem (Int'L Dist. of Electronics For Medicine) · 1999
  • K982249Interacoustics Model AD229 Diagnostic AudiometerIdem (Int'L Dist. of Electronics For Medicine) · 1998
  • K981327Interacoustics Model AD226 Diagnostic AudiometerIdem (Int'L Dist. of Electronics For Medicine) · 1998

All 6 as Idem (Int'L Dist. of Electronics For Medicine) →