The following data is part of a premarket notification filed by Gemss Medical Systems Co. Ltd with the FDA for Gemss Medical Systems Surgical Mobile Fluoroscopic X-ray System.
| Device ID | K132289 |
| 510k Number | K132289 |
| Device Name: | GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | GEMSS MEDICAL SYSTEMS CO. LTD 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | Harvey Knauss |
| Correspondent | Harvey Knauss GEMSS MEDICAL SYSTEMS CO. LTD 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-23 |
| Decision Date | 2014-06-16 |
| Summary: | summary |