The following data is part of a premarket notification filed by Unimed Medical Supplies Inc. with the FDA for Unimed Disposable And Reusable Spo2 Sensors.
| Device ID | K142832 |
| 510k Number | K142832 |
| Device Name: | Unimed Disposable And Reusable SPO2 Sensors |
| Classification | Oximeter |
| Applicant | UNIMED MEDICAL SUPPLIES INC. NO.37, YANSHAN ROAD, SHEKOU Shenzhen, CN 518067 |
| Contact | Xinmei Tan |
| Correspondent | Xinmei Tan UNIMED MEDICAL SUPPLIES INC. NO.37, YANSHAN ROAD, SHEKOU Shenzhen, CN 518067 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2015-02-06 |
| Summary: | summary |