The following data is part of a premarket notification filed by Atom Medical Corporation with the FDA for Bili-therapy Spot Type.
| Device ID | K103828 |
| 510k Number | K103828 |
| Device Name: | BILI-THERAPY SPOT TYPE |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | ATOM MEDICAL CORPORATION 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ATOM MEDICAL CORPORATION 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-28 |
| Decision Date | 2011-03-29 |
| Summary: | summary |