Product code FLA— Gastroenterology, Urology
FLO-TEMP
- Classification name
- Monitor, Temperature, Dialysis
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code FLA
FDA has cleared devices under product code FLA between 1981 and 2014, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2014
- 1984
- 1981
Top applicants under product code FLA
Recent clearances under product code FLA
Data sourced from openFDA. This site is unofficial and independent of the FDA.