The following data is part of a premarket notification filed by Dyna-med with the FDA for Polarix 2 And Polarix 2e.
| Device ID | K884578 |
| 510k Number | K884578 |
| Device Name: | POLARIX 2 AND POLARIX 2E |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | DYNA-MED 3706-B E. RIO GRANDE Victoria, TX 77901 |
| Contact | Thomas, Jr |
| Correspondent | Thomas, Jr DYNA-MED 3706-B E. RIO GRANDE Victoria, TX 77901 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-01 |
| Decision Date | 1989-02-09 |