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All-in-One Health Monitor
Model PC-303 · Shenzhen Creative Industry Co., Ltd. · DI 06941900603523
DQA — Oximeter · Class II · 21 CFR 870.2700
DSH — Recorder, Magnetic Tape, Medical · Class II · 21 CFR 870.2800
DXN — System, Measurement, Blood-Pressure, Non-Invasive · Class II · 21 CFR 870.1130
FLL — Continuous Measurement Thermometer · Class II · 21 CFR 880.2910
MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) · Class II · 21 CFR 870.2300
NBW — System, Test, Blood Glucose, Over The Counter · Class II · 21 CFR 862.1345
UDILibrary device dossier · generated 2026-09-14 · 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
12.67
2019-02
0
15.38
2019-03
0
16.03
2019-04
0
19.79
2019-05
0
18.73
2019-06
0
17.75
2019-07
0
17.5
2019-08
0
16.58
2019-09
0
17.4
2019-10
0
16.18
2019-11
0
12.78
2019-12
0
16.48
2020-01
0
16.91
2020-02
0
13.78
2020-03
0
15.99
2020-04
0
15.49
2020-05
0
17.3
2020-06
0
20.88
2020-07
0
13.15
2020-08
0
11.18
2020-09
0
15.48
2020-10
0
10.88
2020-11
0
14.56
2020-12
0
14.57
2021-01
0
13.03
2021-02
0
12.99
2021-03
0
14.65
2021-04
0
12.67
2021-05
0
13.04
2021-06
0
13.53
2021-07
0
15.49
2021-08
0
12.05
2021-09
0
12.5
2021-10
0
13.17
2021-11
0
12.06
2021-12
0
13.03
2022-01
0
10.48
2022-02
0
10.96
2022-03
0
12.25
2022-04
0
11.52
2022-05
0
14.66
2022-06
0
11.1
2022-07
0
9.64
2022-08
0
7.73
2022-09
0
9.13
2022-10
0
9.64
2022-11
0
9.28
2022-12
0
7.86
2023-01
0
10.34
2023-02
0
11.54
2023-03
0
12.39
2023-04
0
10.99
2023-05
0
26.88
2023-06
0
17.75
2023-07
0
16.93
2023-08
0
17.81
2023-09
0
14.38
2023-10
0
10.47
2023-11
0
12.26
2023-12
0
12.63
2024-01
0
18.65
2024-02
0
10.26
2024-03
0
17.23
2024-04
0
8.95
2024-05
0
12.66
2024-06
0
9.71
2024-07
0
11.29
2024-08
0
9.34
2024-09
0
12.36
2024-10
0
16.85
2024-11
0
11.02
2024-12
0
13.25
2025-01
0
14.81
2025-02
0
9.04
2025-03
0
9.71
2025-04
0
10.21
2025-05
0
9.42
2025-06
0
5.29
2025-07
0
5.87
2025-08
0
6.21
2025-09
0
4.66
2025-10
0
7.44
2025-11
0
5.44
2025-12
0
6.01
2026-01
0
7.07
2026-02
0
5.23
2026-03
0
7.41
2026-04
0
14.55
2026-05
0
8.99
2026-06
0
8.41
This device (reports/month)Average device in DQA, DSH, DXN, FLL, MWI, NBW (reports/device/month)