Portable ECG Monitor— 510(k) K152863
Substantially EquivalentContec Medical Systems Co.,Ltd
FDA 510(k) clearance K152863 for Portable ECG Monitor, Substantially Equivalent on 2016-06-22. Applicant: Contec Medical Systems Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Contec Medical Systems Co.,Ltd
- Product code
- Code DPS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Qinhuangdao, CN
Recent devices under product code DPS
view allMore clearances from Contec Medical Systems Co.,Ltd
view all- K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
- K232895 — B-Ultrasound Diagnostic System
- K232908 — Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)
- K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
- K202757 — CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.