The following data is part of a premarket notification filed by Pausch Llc with the FDA for Hdr Vision, Vision Hdr, Hd R/f, Uromat Hd R/f.
| Device ID | K081073 |
| 510k Number | K081073 |
| Device Name: | HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | PAUSCH LLC 808 SHREWSBURY AVENUE Tinton Falls, NJ 07724 -3002 |
| Contact | Justin Tice |
| Correspondent | Justin Tice PAUSCH LLC 808 SHREWSBURY AVENUE Tinton Falls, NJ 07724 -3002 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-15 |
| Decision Date | 2008-12-05 |
| Summary: | summary |