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 |