NView S1 With Nav Option

Interventional Fluoroscopic X-ray System

NView Medical

The following data is part of a premarket notification filed by Nview Medical with the FDA for Nview S1 With Nav Option.

Pre-market Notification Details

Device IDK211064
510k NumberK211064
Device Name:NView S1 With Nav Option
ClassificationInterventional Fluoroscopic X-ray System
Applicant nView Medical 2681 E Parleys Way STE 107 Salt Lake City,  UT  84109
ContactLisa Last
CorrespondentLisa Last
nView Medical 2681 E Parleys Way STE 107 Salt Lake City,  UT  84109
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeJAK
Subsequent Product CodeOLO
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-09
Decision Date2021-10-29

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