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Nox A1 EEG Head Cable

Model NOX-APSGH1PAC1 · Nox Medical ehf. · DI 15694311110521

KZM — Device, Muscle Monitoring · Class II · 21 CFR 890.1375

OLZ — Automatic Event Detection Software For Polysomnograph With Electroencephalograph · Class II · 21 CFR 882.1400

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.

01122025-01: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1.5/device0108
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2025-0101
2025-0801.5
This device (reports/month)Average device in KZM, OLZ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K192469 — cites (transitively): K072201 (d1), K082113 (d1), K122516 (d1), K041904 (d2), K073682 (d2) — cited as predicate by K223163, K223539, K230148, K240929, K241288, K241960, K252330

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Nox Medical ehf.

Nothing in the loaded window.