The following data is part of a premarket notification filed by Nview Medical, Inc. with the FDA for Nview System 1.
| Device ID | K190064 |
| 510k Number | K190064 |
| Device Name: | NView System 1 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | nView Medical, Inc. 2681 E. Parleys Way Suite 107 Salt Lake City, UT 84109 |
| Contact | Lisa Last |
| Correspondent | Lisa Last nView Medical, Inc. 2681 E. Parleys Way Suite 107 Salt Lake City, UT 84109 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | JAK |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-15 |
| Decision Date | 2019-07-08 |