Product code LLB— Gastroenterology, Urology
BLOOD MONITOR BMM 10-4
- Classification name
- System, Blood, Extracorporeal And Accessories
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code LLB
FDA has cleared devices under product code LLB between 1984 and 1999, filed by 2 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
- 1999
- 1984
Top applicants under product code LLB
Recent clearances under product code LLB
Data sourced from openFDA. This site is unofficial and independent of the FDA.