LBI · Class II · 21 CFR 880.5700

FDA Product Code LBI: Unit, Neonatal Phototherapy

Leading manufacturers include Olympic Medical Corp., Natus Medical Incorporated and Ohmeda Medical.

71
Total
71
Cleared
134d
Avg days
1976
Since
71 devices
49–71 of 71
Cleared Apr 23, 1981
MODEL 533 PHOTOTHERAPY UNIT
K810953
Narco Air-Shields
General Hospital · 16d
Cleared Dec 10, 1980
NEONATAL PHOTOTHERAPY UNIT
K802702
Ohio Medical Products
General Hospital · 37d
Cleared Sep 04, 1979
BILI-DOSIMETER
K791114
Olympic Medical Corp.
General Hospital · 81d
Cleared Oct 25, 1977
PHOTOTHERAPY/PROCEDURE LAMP
K771025
Cavitron Corp.
General Hospital · 139d
Cleared Nov 02, 1976
PHOTOTHERAPY LIGHT
K760872
Air-Shields, Inc.
General Hospital · 15d