The following data is part of a premarket notification filed by Skanray Technologies with the FDA for Intra Skan Dc.
| Device ID | K103579 |
| 510k Number | K103579 |
| Device Name: | INTRA SKAN DC |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | SKANRAY TECHNOLOGIES 78 A&B, HOOTAGALLI INDUSTRIAL AREA Mysore, IN 570017 |
| Contact | Parasuramappa Belur |
| Correspondent | Morten Simon 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 | 2010-12-06 |
| Decision Date | 2011-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D83399927203000 | K103579 | 000 |
| D83399927202000 | K103579 | 000 |
| D83399927201000 | K103579 | 000 |
| D83399927200000 | K103579 | 000 |