The following data is part of a premarket notification filed by Orthosonics, Ltd. with the FDA for Oscar, Model Oe3000db.
| Device ID | K051053 |
| 510k Number | K051053 |
| Device Name: | OSCAR, MODEL OE3000DB |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | ORTHOSONICS, LTD. 2305 GOLD MINE RD. Brookeville, MD 20833 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey ORTHOSONICS, LTD. 2305 GOLD MINE RD. Brookeville, MD 20833 |
| Product Code | JDX |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-25 |
| Decision Date | 2005-07-21 |
| Summary: | summary |