FOK · Class I · 21 CFR 880.5270

FDA Product Code FOK: Pad, Neonatal Eye

Leading manufacturers include Montrose Phototherapy Supply, A & A Medical Supplies Co. and Alba Health Care.

5
Total
5
Cleared
42d
Avg days
1981
Since

FDA 510(k) Cleared Pad, Neonatal Eye Devices (Product Code FOK)

5 devices
1–5 of 5
Cleared Jul 03, 1996
DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER
K962290
Debusk Technology Corp.
General Hospital · 19d
Cleared Mar 15, 1993
LIFE TRACE(R) BILIRUBIN MASK
K926118
Graphic Controls Corp.
General Hospital · 102d
Cleared Jun 07, 1985
INFANT PHOTOTHERAPY MASK
K851918
Alba Health Care
General Hospital · 36d
Cleared Mar 23, 1984
PHOTO-THERAPY EYE PROTECTOR
K840894
A & A Medical Supplies Co.
General Hospital · 25d
Cleared Dec 09, 1981
INFANT PHOTOTHERAPY MASK
K813214
Montrose Phototherapy Supply
General Hospital · 30d

About Product Code FOK - Regulatory Context