The following data is part of a premarket notification filed by Lumitex, Inc. with the FDA for Lulmitex Neonatal Transilluminator.
| Device ID | K912747 |
| 510k Number | K912747 |
| Device Name: | LULMITEX NEONATAL TRANSILLUMINATOR |
| Classification | Transilluminator, Battery-powered |
| Applicant | LUMITEX, INC. 11941 ABBEY ROAD, BLDG. H Cleveland, OH 44133 |
| Contact | Jeffery R Parker |
| Correspondent | Jeffery R Parker LUMITEX, INC. 11941 ABBEY ROAD, BLDG. H Cleveland, OH 44133 |
| Product Code | HJN |
| CFR Regulation Number | 886.1945 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-21 |
| Decision Date | 1991-12-24 |