The following data is part of a premarket notification filed by International Biomedical with the FDA for Airborne Phototherapy Light.
| Device ID | K160238 |
| 510k Number | K160238 |
| Device Name: | Airborne Phototherapy Light |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | INTERNATIONAL BIOMEDICAL 8206 CROSS PARK DR. Austin, TX 78754 |
| Contact | Amy Pieper |
| Correspondent | Amy Pieper INTERNATIONAL BIOMEDICAL 8206 CROSS PARK DR. Austin, TX 78754 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868406000075 | K160238 | 000 |