The following data is part of a premarket notification filed by Unimed Medical Supplies Inc. with the FDA for Unimed Disposable Ecg Lead Wires.
| Device ID | K142489 | 
| 510k Number | K142489 | 
| Device Name: | Unimed Disposable ECG Lead Wires | 
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) | 
| Applicant | UNIMED MEDICAL SUPPLIES INC. NO.37, YANSHAN ROAD, SHEKOU Shenzhen, CN 518067 | 
| Contact | Tan Xinmei | 
| Correspondent | Tan Xinmei UNIMED MEDICAL SUPPLIES INC. NO.37, YANSHAN ROAD, SHEKOU Shenzhen, CN 518067 | 
| Product Code | DSA | 
| CFR Regulation Number | 870.2900 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2014-09-04 | 
| Decision Date | 2014-11-04 | 
| Summary: | summary |