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 |