Omni Infant Phototherapy Unit
FDA 510(k) K834430 · Rocky Mountain Medical Corp.
510(k) numberK834430
Submission
- Device name
- Omni Infant Phototherapy Unit
- Applicant
- Rocky Mountain Medical Corp.
Mchenry, IL, US - Received
- December 16, 1983
- Decision date
- April 30, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LBI – Unit, Neonatal Phototherapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5700
- Specialty
- General Hospital
Other 510(k)s with product code LBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)LBI · Traditional | Thera B Medical Products | 01/15/2026SE |
| K243372 | BiliWrapLBI · Traditional | Gerium Medical, Ltd. | 05/29/2025SE |
| K210289 | Infant Phototherapy EquipmentLBI · Traditional | Bistos Co., Ltd. | 05/28/2021SE |
| K200031 | Neonatal Phototherapy SystemLBI · Traditional | Avalon Biomedical (Shenzhen) Limited | 10/05/2020SE |
| K190899 | bili-hutLBI · Traditional | Little Sparrows Technologies, Inc. | 09/05/2019SE |
| K182178 | neoBLUE blanket LED Phototherapy SystemLBI · Traditional | Natus Medical Incorporated | 12/13/2018SE |
| K172656 | BiliLuxLBI · Traditional | Draeger Medical Systems, Inc. | 05/01/2018SE |
| K170585 | SkylifeLBI · Traditional | Neolight, LLC | 10/27/2017SE |
| K163526 | Bilicocoon Phototherapy SystemLBI · Traditional | Neomedlight | 10/06/2017SE |
| K160745 | neoBLUE compact LED Phototherapy SystemLBI · Traditional | Natus Medical Incorporated | 12/12/2016SE |
More from Natus Medical Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K890202 | Tele-Temp ThermometerFLL · Traditional | 04/05/1989SE |
| K860120 | Nursery Ambient Light MeterFMS · Traditional | 02/19/1986SE |
| K852167 | Isovol-Exchange TrayBRZ · Traditional | 11/18/1985SE |
| K853970 | Alpha ChuckKME · Traditional | 11/08/1985SE |
| K853790 | Babe Shade-Infant Ambient Light Intensity ReducerHQY · Traditional | 10/04/1985SE |
| K851876 | Prefer Incontinence AidEYQ · Traditional | 06/12/1985SE |
| K832298 | Baby Light DosimeterLBI · Traditional | 10/19/1983SE |
| K837494 | Baby Light Meter · Traditional | 06/14/1983SE |
Questions and answers
When was Omni Infant Phototherapy Unit cleared by the FDA?
Omni Infant Phototherapy Unit (K834430) received a 510(k) decision of Substantially Equivalent on April 30, 1984, 136 days after the submission was received.
What is the product code of K834430?
The FDA product code is LBI – Unit, Neonatal Phototherapy, a Class II (moderate risk) device regulated under 21 CFR 880.5700.