The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Aequitron Med-7100 Phototherapy Light.
| Device ID | K850181 |
| 510k Number | K850181 |
| Device Name: | AEQUITRON MED-7100 PHOTOTHERAPY LIGHT |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Contact | Robert C Samec |
| Correspondent | Robert C Samec AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-18 |
| Decision Date | 1985-04-05 |