510(k) K050303
K050303 is an FDA 510(k) premarket notification submitted by Mesure Technology Co., Ltd. for the device "5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X.". The FDA issued a decision of Substantially Equivalent on Feb 25, 2005. The device falls under product code FLL (Continuous Measurement Thermometer), a Class II device regulated under 21 CFR 880.2910. Mesure Technology Co., Ltd. has 7 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 25, 2005
- Date Received
- Feb 8, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Continuous Measurement Thermometer
- Device Class
- Class II
- Regulation Number
- 880.2910
- Review Panel
- HO
- Submission Type
- 510(k)
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.