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 |