FDA Product Code
FDA Product Code FOK — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5270
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K962290 | DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER | Debusk Technology Corp. | 1996-07-03 | Traditional | PDF ↗ |
| K926118 | LIFE TRACE(R) BILIRUBIN MASK | Graphic Controls Corp. | 1993-03-15 | Traditional | PDF ↗ |
| K851918 | INFANT PHOTOTHERAPY MASK | Alba Health Care | 1985-06-07 | Traditional | PDF ↗ |
| K840894 | PHOTO-THERAPY EYE PROTECTOR | A & A Medical Supplies Co. | 1984-03-23 | Traditional | PDF ↗ |
| K813214 | INFANT PHOTOTHERAPY MASK | Montrose Phototherapy Supply | 1981-12-09 | Traditional | PDF ↗ |
Product code FOK · Class I · General Hospital. Data: openFDA.