The following data is part of a premarket notification filed by Owandy with the FDA for Visteo.
| Device ID | K093105 |
| 510k Number | K093105 |
| Device Name: | VISTEO |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | OWANDY 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour OWANDY 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-01 |
| Decision Date | 2010-10-18 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VISTEO 78775453 not registered Dead/Abandoned |
Harmonic, Inc. 2005-12-16 |