Submission Details
| 510(k) Number | K121427 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 14, 2012 |
| Decision Date | May 29, 2012 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
UNIMED TEMPERATURE PROBE
May 2012
Decision
15d
Days
Class 2
Risk
About This 510(k) Submission
K121427 is an FDA 510(k) clearance for the UNIMED TEMPERATURE PROBE, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Unimed Medical Supplies, Inc. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on May 29, 2012, 15 days after receiving the submission on May 14, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.
Device Classification
| Product Code | FLL — Continuous Measurement Thermometer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2910 |
| Definition | A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf. |
Manufacturer
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