Contec Medical System Co., Ltd.
Zhong Shan, Shanghai, CN
Contec Medical System Co., Ltd. appears in FDA device records in Zhong Shan, Shanghai, CN. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Contec Medical System Co., Ltd. between 2008 and 2019. The busiest year on record is 2011, with 4. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 4 |
| 2014 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K180837 | CONTEC Oxygen Concentrator | CAW | Substantially Equivalent | |
| K131900 | CONTEC ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K101273 | DYNAMIC ECG SYSTEM MODEL TLC5000 | MLO | Substantially Equivalent | |
| K110156 | AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER, | DXN | Substantially Equivalent | |
| K101692 | PATIENT MONITOR | MHX | Substantially Equivalent | |
| K110774 | ELECTRONIC SPHYGMOMANOMETER | DXN | Substantially Equivalent | |
| K101127 | PATIENT MONITOR, MODEL PM50 | MWI | Substantially Equivalent | |
| K090936 | SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A | DPS | Substantially Equivalent | |
| K090671 | PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D | DQA | Substantially Equivalent | |
| K082480 | CONTEC POCKET FETAL DOPPLER | KNG | Substantially Equivalent | |
| K082641 | FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL | DQA | Substantially Equivalent | |
| K073454 | FINGERTIP PULSE OXIMETER, MODEL CMS-50C | DQA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DPSElectrocardiograph
- MLOElectrocardiograph, Ambulatory, With Analysis Algorithm
- CAWGenerator, Oxygen, Portable
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- KNGMonitor, Ultrasonic, Fetal
- DQAOximeter
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain