The following data is part of a premarket notification filed by O.p.t. Usa, Inc. with the FDA for Opt80 The Transportable (opt80).
| Device ID | K972810 |
| 510k Number | K972810 |
| Device Name: | OPT80 THE TRANSPORTABLE (OPT80) |
| Classification | Table, Operating-room, Ac-powered |
| Applicant | O.P.T. USA, INC. 235 SACKETT ST. Brooklyn, NY 11231 |
| Contact | Maria Coria |
| Correspondent | Maria Coria O.P.T. USA, INC. 235 SACKETT ST. Brooklyn, NY 11231 |
| Product Code | FQO |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-28 |
| Decision Date | 1997-08-26 |
| Summary: | summary |