510(k) K240223
K240223 is an FDA 510(k) premarket notification submitted by Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi for the device "FMT Disposable and Autoclavable Temperature Probes". The FDA issued a decision of Substantially Equivalent on October 25, 2024. The device falls under product code FLL (Continuous Measurement Thermometer), a Class II device regulated under 21 CFR 880.2910.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2024
- Date Received
- January 26, 2024
- Clearance Type
- Traditional
- 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
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.