FRA · Class II · 21 CFR 880.6500

FDA Product Code FRA: Purifier, Air, Ultraviolet, Medical

Leading manufacturers include Molekule, Inc., Healkee Medical Pte, Ltd. and Schiff & Co..

36
Total
36
Cleared
209d
Avg days
1987
Since
36 devices
25–36 of 36
Cleared Apr 02, 1999
SECOND WIND AIR PURIFIER
K980745
Monagan Ent., Inc.
General Hospital · 400d
Cleared Dec 01, 1997
MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV
K972064
Biological Controls, Inc.
General Hospital · 181d
Cleared Oct 28, 1996
VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
K954448
Schiff & Co.
General Hospital · 399d
Cleared Jul 25, 1996
VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
K960833
Uv Technologies, Inc.
General Hospital · 147d
Cleared Oct 12, 1995
RXAIR 3000
K951981
Clean Air Research & Development
General Hospital · 168d
Cleared Feb 14, 1995
VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE
K943521
Schiff & Co.
General Hospital · 209d
Cleared Sep 16, 1994
DYNAMIC GERMICIDAL AIR PURIFICATION SYSTEM
K933454
L&H Airco
General Hospital · 429d
Cleared May 12, 1994
CLESTRACLEAN(R) ROOM AIR PURIFIER
K932803
Clestra Cleanroom Technology, Inc.
General Hospital · 337d
Cleared Apr 13, 1994
ICS 9400 ULTRAVIOLET AIR PURIFIER
K934914
Medair, Inc.
General Hospital · 182d
Cleared Apr 07, 1993
STRAIGHT-LINES I.V. ORGANIZER
K920965
Taylor Bio-Medical, Inc.
General Hospital · 401d
Cleared Dec 12, 1988
UV AIR STERILIGHT
K884579
Allseasons Environmental Control, Inc.
General Hospital · 39d
Cleared Jan 13, 1987
AIR CARE AIR SANITIZER
K860132
Cooper-Hewitt Electric Co.
General Hospital · 364d