FLI · Class II · 21 CFR 880.6100

FDA Product Code FLI: Cabinet, Ethylene-oxide Gas Aerator

Leading manufacturers include Bear Medical Systems, Inc., 3M Health Care, Ltd. and Sybron Corp..

8
Total
8
Cleared
56d
Avg days
1977
Since

FDA 510(k) Cleared Cabinet, Ethylene-oxide Gas Aerator Devices (Product Code FLI)

8 devices
1–8 of 8
Cleared Dec 05, 1990
STERI-VAC(TM) AERATOR MODEL XL
K904921
3M Health Care, Ltd.
General Hospital · 35d
Cleared Apr 12, 1983
BEAR JET 150 VENTILATOR
K830165
Bear Medical Systems, Inc.
General Hospital · 84d
Cleared Dec 31, 1981
CASTLE #3241 GAS AERATOR
K813201
Sybron Corp.
General Hospital · 48d

About Product Code FLI - Regulatory Context