LIFE TRACE(R) BILIRUBIN MASK
FDA 510(k) clearance K926118 · decided 1993-03-15
Clearance details
- K-number
- K926118
- Device name
- LIFE TRACE(R) BILIRUBIN MASK
- Applicant
- Graphic Controls Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-12-03
- Decision date
- 1993-03-15
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- FOK
- Device class
- 1
- Regulation number
- 880.5270
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Buffalo, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER (K962290) | Debusk Technology Corp. | 1996-07-03 |
| 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.