The following data is part of a premarket notification filed by Unimed Medical Supplies Inc. with the FDA for Unimed Temperature Probe.
| Device ID | K121427 |
| 510k Number | K121427 |
| Device Name: | UNIMED TEMPERATURE PROBE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | UNIMED MEDICAL SUPPLIES INC. NO.37, YANSHAN ROAD, SHEKOU Shenzhen, Guangdong, CN 518067 |
| Contact | Xinmei Tan |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-05-14 |
| Decision Date | 2012-05-29 |
| Summary: | summary |