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Alice 6

Model Alice 6 Base Station, LDx with Masimo, INTL · Respironics, Inc. · DI 00606959047136

OLV — Standard Polysomnograph With Electroencephalograph · Class II · 21 CFR 882.1400

UDILibrary device dossier · generated 2026-09-12 · 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.

11222019-01: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 2/device0106021011120406010910
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0601
2022-0202
2022-1001
2022-1101
2022-1201
2024-0402
2024-0602
2025-0101
2025-0901
2025-1002
This device (reports/month)Average device in OLV (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Respironics, Inc.

  • OAI 2023-02-14 Respironics, Inc. · 1 citations
  • NAI 2016-12-07 Respironics, Inc. · 0 citations
  • NAI 2015-01-28 Respironics, Inc. · 0 citations
  • NAI 2012-06-15 Respironics, Inc. · 0 citations
  • NAI 2010-09-01 Respironics, Inc. · 0 citations
  • NAI 2010-06-22 Respironics, Inc. · 0 citations