Portable ECG Monitor
FDA 510(k) K152863 · Contec Medical Systems Co.,Ltd
510(k) numberK152863
Submission
- Device name
- Portable ECG Monitor
- Applicant
- Contec Medical Systems Co.,Ltd
Qinhuangdao, CN - Received
- September 30, 2015
- Decision date
- June 22, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
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| K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal…KNG · Traditional | 06/14/2024SE |
| K232895 | B-Ultrasound Diagnostic SystemIYO · Traditional | 05/03/2024SE |
| K232908 | Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…IYN · Traditional | 05/02/2024SE |
| K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)KNG · Traditional | 09/28/2022SE |
| K202757 | CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50…DXN · Traditional | 04/28/2021SE |
| K201980 | Infrared ThermometerFLL · Traditional | 12/18/2020SE |
| K171360 | CONTEC ElectrocardiographDPS · Traditional | 01/22/2018SE |
| K170856 | CMS600P2 B-Ultrasound Diagnostic SystemIYO · Traditional | 11/17/2017SE |
| K170954 | Portable ECG MonitorDPS · Traditional | 05/30/2017SE |
| K141362 | Pulse Oximeter CMS50EWDQA · Traditional | 04/23/2015SE |
Questions and answers
When was Portable ECG Monitor cleared by the FDA?
Portable ECG Monitor (K152863) received a 510(k) decision of Substantially Equivalent on June 22, 2016, 266 days after the submission was received.
What is the product code of K152863?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.