The following data is part of a premarket notification filed by Owandy with the FDA for Krystal-x Wifi.
| Device ID | K070505 |
| 510k Number | K070505 |
| Device Name: | KRYSTAL-X WIFI |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | OWANDY 110 EAST GRANADA BLVD SUITE 207 Ormond Beach, FL 32176 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin OWANDY 110 EAST GRANADA BLVD SUITE 207 Ormond Beach, FL 32176 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-21 |
| Decision Date | 2007-04-05 |
| Summary: | summary |