The following data is part of a premarket notification filed by Vatech Value Added Technology Co., Ltd with the FDA for Hds Intra-oral Imaging System.
| Device ID | K042372 |
| 510k Number | K042372 |
| Device Name: | HDS INTRA-ORAL IMAGING SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | VATECH VALUE ADDED TECHNOLOGY CO., LTD P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm VATECH VALUE ADDED TECHNOLOGY CO., LTD P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-31 |
| Decision Date | 2004-10-04 |
| Summary: | summary |