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Polysmith
Model 12.3 · Neurotronics, LLC · DI 00817111021332
DQA — Oximeter · Class II · 21 CFR 870.2700
GWL — Amplifier, Physiological Signal · Class II · 21 CFR 882.1835
MLO — Electrocardiograph, Ambulatory, With Analysis Algorithm · Class II · 21 CFR 870.2800
MNR — Ventilatory Effort Recorder · Class II · 21 CFR 868.2375
OLV — Standard Polysomnograph With Electroencephalograph · Class II · 21 CFR 882.1400
OLZ — Automatic Event Detection Software For Polysomnograph With 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
10.32
2019-02
0
11.13
2019-03
0
8.57
2019-04
0
9.4
2019-05
0
8.47
2019-06
0
7.53
2019-07
0
8.03
2019-08
0
9.07
2019-09
0
12
2019-10
0
9.49
2019-11
0
8.85
2019-12
0
10.21
2020-01
0
9.41
2020-02
0
8.76
2020-03
0
8.76
2020-04
0
13.14
2020-05
0
9.03
2020-06
0
8.18
2020-07
0
7.98
2020-08
0
8.91
2020-09
0
10.35
2020-10
0
10.15
2020-11
0
11.16
2020-12
0
10.8
2021-01
0
10.02
2021-02
0
10.55
2021-03
0
14
2021-04
0
8.9
2021-05
0
7.47
2021-06
0
9.93
2021-07
0
8.43
2021-08
0
7.77
2021-09
0
7.44
2021-10
0
10
2021-11
0
10.34
2021-12
0
7.63
2022-01
0
7.16
2022-02
0
8.17
2022-03
0
11.32
2022-04
0
11.07
2022-05
0
14.38
2022-06
0
10.68
2022-07
0
7.27
2022-08
0
9.14
2022-09
0
11.87
2022-10
0
16.16
2022-11
0
8.93
2022-12
0
12.07
2023-01
0
9.5
2023-02
0
17.23
2023-03
0
19.41
2023-04
0
21.93
2023-05
0
21.78
2023-06
0
14.49
2023-07
0
27.29
2023-08
0
31.62
2023-09
0
32.73
2023-10
0
21.05
2023-11
0
31.3
2023-12
0
28.36
2024-01
0
26.6
2024-02
0
23.95
2024-03
0
29.47
2024-04
0
16.52
2024-05
0
18.2
2024-06
0
15.33
2024-07
0
26.88
2024-08
0
24.49
2024-09
0
30.13
2024-10
0
36.26
2024-11
0
26.81
2024-12
0
22.65
2025-01
0
26.42
2025-02
0
21.64
2025-03
0
27.27
2025-04
0
17.38
2025-05
0
14.41
2025-06
0
10.52
2025-07
0
10.16
2025-08
0
8.38
2025-09
0
9.16
2025-10
0
13.24
2025-11
0
8.41
2025-12
0
10.95
2026-01
0
11.25
2026-02
0
10.2
2026-03
0
11.79
2026-04
0
31.1
2026-05
0
15.68
2026-06
0
13.5
This device (reports/month)Average device in DQA, GWL, MLO, MNR, OLV, OLZ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Neurotronics, LLC