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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K190064
Device Name nView system 1
Applicant
nView medical, Inc.
2681 E. Parleys Way Suite 107
Salt Lake City,  UT  84109
Applicant Contact Lisa Last
Correspondent
nView medical, Inc.
2681 E. Parleys Way Suite 107
Salt Lake City,  UT  84109
Correspondent Contact Lisa Last
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   JAK   OXO  
Date Received01/15/2019
Decision Date 07/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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