Product code FNC— Anesthesiology

THE BREATHE EASE NURSERY VAPOR TENT

Classification name
Tent, Pediatric Aerosol
Device class
Class 2
Regulation
21 CFR 868.5710
Advisory panel
Anesthesiology
Total cleared
1
First cleared
Most recent

Market context for product code FNC

FDA has cleared 1 device under product code FNC, all in 1989, 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 FNC

Recent clearances under product code FNC

Data sourced from openFDA. This site is unofficial and independent of the FDA.