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 |