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1066 OTOsuite

Model 8-49-88000 · Natus Medical Denmark ApS · DI 05713315000751

EWO — Audiometer · Class II · 21 CFR 874.1050

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

01122022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1.5/device2025-06: 0 reports for this device; peer average 1/device03040906
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-0301
2022-0401
2023-0901.5
2025-0601
This device (reports/month)Average device in EWO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Natus Medical Denmark ApS

  • NAI 2015-03-12 Natus Medical Denmark ApS · 0 citations
  • NAI 2015-03-12 Natus Medical Denmark ApS · 0 citations
  • VAI 2012-01-12 Natus Medical Denmark ApS · 3 citations
  • VAI 2012-01-12 Natus Medical Denmark ApS · 3 citations