The following data is part of a premarket notification filed by Gemss Medical Systems Co., Ltd with the FDA for Titan 11.
| Device ID | K133695 |
| 510k Number | K133695 |
| Device Name: | TITAN 11 |
| Classification | System, X-ray, Stationary |
| Applicant | GEMSS MEDICAL SYSTEMS CO., LTD 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Contact | Dave Kim |
| Correspondent | Dave Kim GEMSS MEDICAL SYSTEMS CO., LTD 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-03 |
| Decision Date | 2014-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809246620032 | K133695 | 000 |