ELECTRONIC SPHYGMOMANOMETER— 510(k) K110775

Clearance details

Applicant

Contec Medical Systems Co.,Ltd

Product code

Code DXN

Device class

Class 2

Regulation

21 CFR 870.1130

Advisory panel

Cardiovascular

Date received

2011-03-21

Decision date

2011-05-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shanghai, CN

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• K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)2024-06-14
• K232895 — B-Ultrasound Diagnostic System2024-05-03
• K232908 — Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)2024-05-02
• K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)2022-09-28
• K202757 — CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor2021-04-28

Death

3

Injury

169

Malfunction

1,019

Other

2

Total

1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →