The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Biliblanket Phototherapy Device.
| Device ID | K894129 |
| 510k Number | K894129 |
| Device Name: | BILIBLANKET PHOTOTHERAPY DEVICE |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
| Contact | Alberto Profumo |
| Correspondent | Alberto Profumo OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-12 |
| Decision Date | 1989-09-28 |