Product code FJC— Gastroenterology, Urology
WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT
- Classification name
- Detector, Blood Level
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code FJC
FDA has cleared device under product code FJC, all in 1995, filed by 1 applicant company. 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.
Top applicants under product code FJC
Recent clearances under product code FJC
Data sourced from openFDA. This site is unofficial and independent of the FDA.