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 |