The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Biliblanket Plus High Output Phototherapy System.
| Device ID | K993712 |
| 510k Number | K993712 |
| Device Name: | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM |
| Classification | Incubator, Neonatal |
| 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 | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-03 |
| Decision Date | 1999-11-09 |
| Summary: | summary |