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 |