Panels › General Hospital › Product code FOK · Class 1
Pad, Neonatal Eye
Regulation 880.5270
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FOK
| Company | 510(k)s | Recalls |
|---|---|---|
| A & A Medical Supplies Co. | 1 | 0 |
| Alba Health Care | 1 | 0 |
| Debusk Technology Corp. | 1 | 0 |
| Graphic Controls Corp. | 1 | 0 |
| Montrose Phototherapy Supply | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 3, 1996 | K962290 | DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER Debusk Technology Corp. | FOK |
| Mar 15, 1993 | K926118 | LIFE TRACE(R) BILIRUBIN MASK Graphic Controls Corp. | FOK |
| Jun 7, 1985 | K851918 | INFANT PHOTOTHERAPY MASK Alba Health Care | FOK |
| Mar 23, 1984 | K840894 | PHOTO-THERAPY EYE PROTECTOR A & A Medical Supplies Co. | FOK |
| Dec 9, 1981 | K813214 | INFANT PHOTOTHERAPY MASK Montrose Phototherapy Supply | FOK |
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