FOK · Pad, Neonatal Eye
General Hospital · 21 CFR 880.5270 · Class 1
Overview
| Product Code | FOK |
|---|---|
| Device Name | Pad, Neonatal Eye |
| Regulation | 21 CFR 880.5270 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962290 | DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER | Debusk Technology Corp. | Jul 3, 1996 | SESE |
| K926118 | LIFE TRACE(R) BILIRUBIN MASK | Graphic Controls Corp. | Mar 15, 1993 | SESE |
| K851918 | INFANT PHOTOTHERAPY MASK | Alba Health Care | Jun 7, 1985 | SESE |
| K840894 | PHOTO-THERAPY EYE PROTECTOR | A & A Medical Supplies Co. | Mar 23, 1984 | SESE |
| K813214 | INFANT PHOTOTHERAPY MASK | Montrose Phototherapy Supply | Dec 9, 1981 | SESE |
Top Applicants
- A & A Medical Supplies Co. — 1 clearance
- Alba Health Care — 1 clearance
- Debusk Technology Corp. — 1 clearance
- Graphic Controls Corp. — 1 clearance
- Montrose Phototherapy Supply — 1 clearance
