The following data is part of a premarket notification filed by Wuestec Medical, Inc. with the FDA for Xrt 600 R/f, Wrf 0600.
| Device ID | K992603 |
| 510k Number | K992603 |
| Device Name: | XRT 600 R/F, WRF 0600 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | WUESTEC MEDICAL, INC. 5600 COMMERCE BLVD., EAST Mobile, AL 36619 -0037 |
| Contact | Brenda S Davis |
| Correspondent | Brenda S Davis WUESTEC MEDICAL, INC. 5600 COMMERCE BLVD., EAST Mobile, AL 36619 -0037 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-03 |
| Decision Date | 1999-10-25 |