The following data is part of a premarket notification filed by Nview Medical with the FDA for Nview S1 With Nav Option.
Device ID | K211064 |
510k Number | K211064 |
Device Name: | NView S1 With Nav Option |
Classification | Interventional Fluoroscopic X-ray System |
Applicant | nView Medical 2681 E Parleys Way STE 107 Salt Lake City, UT 84109 |
Contact | Lisa Last |
Correspondent | Lisa Last nView Medical 2681 E Parleys Way STE 107 Salt Lake City, UT 84109 |
Product Code | OWB |
Subsequent Product Code | JAA |
Subsequent Product Code | JAK |
Subsequent Product Code | OLO |
Subsequent Product Code | OXO |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-09 |
Decision Date | 2021-10-29 |