FOK — Pad, Neonatal Eye Class I
FDA product code FOK covers "Pad, Neonatal Eye", a Class I medical device regulated under 21 CFR 880.5270. Submissions are reviewed by the General Hospital panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FOK
- Device Class
- Class I
- Regulation Number
- 880.5270
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K962290 | debusk technology | DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER | July 3, 1996 |
| K926118 | graphic controls | LIFE TRACE(R) BILIRUBIN MASK | March 15, 1993 |
| K851918 | alba health care | INFANT PHOTOTHERAPY MASK | June 7, 1985 |
| K840894 | a and a medical supplies | PHOTO-THERAPY EYE PROTECTOR | March 23, 1984 |
| K813214 | montrose phototherapy supply | INFANT PHOTOTHERAPY MASK | December 9, 1981 |