The following data is part of a premarket notification filed by Oasys Healthcare with the FDA for Oasys Surgical Light Controller.
| Device ID | K112133 |
| 510k Number | K112133 |
| Device Name: | OASYS SURGICAL LIGHT CONTROLLER |
| Classification | Light, Surgical, Accessories |
| Applicant | OASYS HEALTHCARE 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Tanya M O'brien |
| Correspondent | Tanya M O'brien OASYS HEALTHCARE 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | FTA |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-26 |
| Decision Date | 2012-03-01 |
| Summary: | summary |