The following data is part of a premarket notification filed by Skanray Technologies with the FDA for Air Techniques High Frequency Intra-oral X-ray.
| Device ID | K111330 |
| 510k Number | K111330 |
| Device Name: | AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | SKANRAY TECHNOLOGIES PLOT 15-17 HEBBAL INDUSTRIAL AREA Mysore, IN 570016 |
| Contact | Parasuramappa Belur |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-05-11 |
| Decision Date | 2011-05-27 |
| Summary: | summary |