LBI · Class II · 21 CFR 880.5700

FDA Product Code LBI: Unit, Neonatal Phototherapy

Leading manufacturers include Olympic Medical Corp., Natus Medical Incorporated and Air-Shields, Inc..

71
Total
71
Cleared
134d
Avg days
1976
Since
71 devices
25–48 of 71
Cleared Feb 27, 2009
MEDILED PHOTOTHERAPY LAMP
K083179
Medix I.C.S.A.
General Hospital · 122d
Cleared Oct 30, 2007
BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1
K072097
Medical Select, Inc.
General Hospital · 91d
Cleared Aug 06, 2007
LULLABY
K071828
Ge Healthcare Clinical Systems
General Hospital · 34d
Cleared May 18, 2007
WALLABY 4
K070180
Respironics Inc., Sleep & Home Respiratory Group
General Hospital · 119d
Cleared Apr 17, 2006
BILISOFT PHOTOTHERAPY SYSTEM
K053568
Lumitex, Inc.
General Hospital · 116d
Cleared Oct 07, 2005
NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
K051869
Natus Medical, Inc.
General Hospital · 88d
Cleared Jul 19, 2001
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
K011549
Ohmeda Medical
General Hospital · 62d
Cleared Sep 25, 2000
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
K002414
Fisher &Paykel Healthcare , Ltd.
General Hospital · 49d
Cleared May 17, 1999
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
K991627
Respironics, Inc.
General Hospital · 6d
Cleared Apr 20, 1999
PHOTOTHERAPY LAMP
K984589
Medela, Inc.
General Hospital · 117d
Cleared May 20, 1998
ULTRA BILI LIGHT
K974830
Physician Engineered Products, Inc.
General Hospital · 147d
Cleared Sep 24, 1997
DUO-LITE PHOTOTHERAPY SYSTEM
K971256
Air-Shields, Inc.
General Hospital · 173d
Cleared Sep 24, 1997
OLYMPIC BILI-BASSINET
K971601
Olympic Medical Corp.
General Hospital · 146d
Cleared Dec 12, 1996
BILIBED PHOTOTHERAPY LAMP
K962612
Medela, Inc.
General Hospital · 162d
Cleared Dec 01, 1995
DRAGER PT4000 PHOTOTHERAPY SYSTEM
K954611
Drager, Inc.
General Hospital · 58d
Cleared Sep 16, 1994
OLYMPIC BILI-LITE
K940996
Olympic Medical Corp.
General Hospital · 196d
Cleared Jul 28, 1992
BILIBLANKET LIGHT METER
K910571
Ohmeda Medical
General Hospital · 533d
Cleared Oct 29, 1990
OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR
K903445
Olympic Medical Corp.
General Hospital · 90d
Cleared Aug 02, 1990
OLYMPIC MINI BILI-LITE, MODEL 77
K902749
Olympic Medical Corp.
General Hospital · 41d
Cleared Jul 16, 1990
OLYMPIC BILI-LITE-PAD(TM)
K901987
Olympic Medical Corp.
General Hospital · 75d
Cleared Sep 28, 1989
BILIBLANKET PHOTOTHERAPY DEVICE
K894129
Ohmeda Medical
General Hospital · 108d
Cleared Apr 05, 1985
AEQUITRON MED-7100 PHOTOTHERAPY LIGHT
K850181
Aequitron Medical, Inc.
General Hospital · 77d
Cleared Mar 23, 1984
PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO
K840454
Air-Shields, Inc.
General Hospital · 60d
Cleared Feb 16, 1983
MICROELISA MINIREADER II
K830200
Dynatech Corp.
Chemistry · 27d