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Zmachine
Model Synergy · General Sleep · DI B566847002
MNR — Ventilatory Effort Recorder · Class II · 21 CFR 868.2375
OLV — Standard Polysomnograph With Electroencephalograph · Class II · 21 CFR 882.1400
OMC — Reduced- Montage Standard Electroencephalograph · Class II · 21 CFR 882.1400
UDILibrary device dossier · generated 2026-09-15 · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2
2019-06
0
1
2020-03
0
1
2020-06
0
1
2020-07
0
1
2021-03
0
2
2021-09
0
2
2021-10
0
1.5
2021-12
0
2
2022-01
0
2
2022-02
0
2
2022-05
0
1
2022-09
0
1
2022-10
0
1
2022-11
0
1
2022-12
0
1
2023-01
0
1
2023-02
0
1
2023-05
0
4.33
2023-07
0
2
2023-08
0
1
2023-12
0
1
2024-01
0
4
2024-03
0
2
2024-04
0
1.5
2024-06
0
2
2024-08
0
9
2024-09
0
1
2025-01
0
1.25
2025-02
0
2
2025-03
0
2
2025-04
0
2
2025-05
0
2
2025-06
0
1.25
2025-07
0
3.5
2025-08
0
2
2025-09
0
1
2025-10
0
1.75
2025-11
0
3.5
2025-12
0
1.33
2026-01
0
4.5
2026-02
0
4
2026-03
0
3
2026-04
0
4.5
2026-05
0
1.5
2026-06
0
2
This device (reports/month)Average device in MNR, OLV, OMC (reports/device/month)