The following data is part of a premarket notification filed by Unimed Medical Supplies Inc. with the FDA for Patient Monitoring Cables For Ecg, Ekg, Spo2 And Blood Pressure Monitors.
Device ID | K082959 |
510k Number | K082959 |
Device Name: | PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS |
Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
Applicant | UNIMED MEDICAL SUPPLIES INC. NO.37, YANSHAN ROAD, SHEKOU Shenzhen, Guangdong, CN 518067 |
Contact | Liming Xue |
Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | DSA |
CFR Regulation Number | 870.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2008-10-03 |
Decision Date | 2008-10-10 |
Summary: | summary |