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 |