The following data is part of a premarket notification filed by Orthosonics, Ltd. with the FDA for Oscar 3.
| Device ID | K093805 |
| 510k Number | K093805 |
| Device Name: | OSCAR 3 |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | ORTHOSONICS, LTD. BREMRIDGE HOUSE Ashburton, Devon, GB Tq137jx |
| Contact | Michael J.r. Young, Ph.d. |
| Correspondent | Michael J.r. Young, Ph.d. ORTHOSONICS, LTD. BREMRIDGE HOUSE Ashburton, Devon, GB Tq137jx |
| Product Code | JDX |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-11 |
| Decision Date | 2010-02-19 |
| Summary: | summary |