The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Biliblanket Light Meter.
| Device ID | K910571 |
| 510k Number | K910571 |
| Device Name: | BILIBLANKET LIGHT METER |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
| Contact | Alberto F Profumo |
| Correspondent | Alberto F 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 | 1991-02-11 |
| Decision Date | 1992-07-28 |