The following data is part of a premarket notification filed by Rocky Mountain Medical Corp. with the FDA for Omni Infant Phototherapy Unit.
| Device ID | K834430 |
| 510k Number | K834430 |
| Device Name: | OMNI INFANT PHOTOTHERAPY UNIT |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | ROCKY MOUNTAIN MEDICAL CORP. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-16 |
| Decision Date | 1984-04-30 |