DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER
FDA 510(k) clearance K962290 · decided 1996-07-03
Clearance details
- K-number
- K962290
- Device name
- DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER
- Applicant
- Debusk Technology Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-14
- Decision date
- 1996-07-03
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- FOK
- Device class
- 1
- Regulation number
- 880.5270
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Powell, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Debusk Technology Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LIFE TRACE(R) BILIRUBIN MASK (K926118) | Graphic Controls Corp. | 1993-03-15 |
| INFANT PHOTOTHERAPY MASK (K851918) | Alba Health Care | 1985-06-07 |
| PHOTO-THERAPY EYE PROTECTOR (K840894) | A & A Medical Supplies Co. | 1984-03-23 |
| INFANT PHOTOTHERAPY MASK (K813214) | Montrose Phototherapy Supply | 1981-12-09 |
Recalls involving this device
No recalls on record reference this clearance.