Product code FLI— General Hospital
BEAR JET 150 VENTILATOR
- Classification name
- Cabinet, Ethylene-Oxide Gas Aerator
- Device class
- Class 2
- Regulation
- 21 CFR 880.6100
- Advisory panel
- General Hospital
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code FLI
FDA has cleared devices under product code FLI between 1977 and 1990, filed by 6 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
- 1990
- 1983
- 1981
- 1979
- 1978
- 1977
Top applicants under product code FLI
Recent clearances under product code FLI
- K904921 — STERI-VAC(TM) AERATOR MODEL XL
- K902906 — GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR
- K831595 — CASTLE MODEL 3341 & 3441 & 4141 GAS AER
- K830165 — BEAR JET 150 VENTILATOR
- K813201 — CASTLE #3241 GAS AERATOR
- K790677 — EO EVACUATING SYSTEM I
- K781484 — CASTLE MODEL 3146 GAS AERATOR
- K761341 — PORTAGAS AERATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.