The following data is part of a premarket notification filed by Telesystems Co., Ltd. with the FDA for Qmaster-h/revo.
| Device ID | K133797 |
| 510k Number | K133797 |
| Device Name: | QMASTER-H/REVO |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | TELESYSTEMS CO., LTD. 110 EAST GRANADA BLVD. Ormond Beach, FL 32176 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin TELESYSTEMS CO., LTD. 110 EAST GRANADA BLVD. Ormond Beach, FL 32176 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-13 |
| Decision Date | 2014-09-04 |
| Summary: | summary |