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"SleepmateRIPmate Belt - Adult 1-1/2"" Band (26-65"")"

Model 819103-000 · Ambu A/S · DI 05707480041084

BZQ — Monitor, Breathing Frequency · Class II · 21 CFR 868.2375

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.

12342021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 1.5/device2025-04: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1.5/device2025-10: 0 reports for this device; peer average 3.5/device2025-12: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 2/device0910040509020406081012030406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0902
2021-1001
2024-0401
2024-0501
2024-0901
2025-0201.5
2025-0401
2025-0601
2025-0801.5
2025-1003.5
2025-1201.5
2026-0301
2026-0401
2026-0602
This device (reports/month)Average device in BZQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Ambu A/S

  • VAI 2016-05-20 AMBU Limited · 0 citations
  • VAI 2016-04-15 Ambu Sdn. Bhd. · 0 citations
  • VAI 2013-11-07 AMBU Limited · 2 citations
  • VAI 2013-09-19 Ambu Sdn. Bhd. · 5 citations
  • NAI 2013-06-19 Ambu A/S · 0 citations
  • NAI 2013-06-19 Ambu A/S · 0 citations
  • VAI 2011-06-02 AMBU Limited · 2 citations
  • NAI 2010-02-09 Ambu A/S · 0 citations
  • NAI 2010-02-09 Ambu A/S · 0 citations