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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K193218
Device Name Innovision Audio
Applicant
Innovere Medical, Inc.
6-250 Shields Ct.
Markham,  CA L3R 9W7
Applicant Contact Lynsie Thomason
Correspondent
Innovere Medical, Inc.
6-250 Shields Ct.
Markham,  CA L3R 9W7
Correspondent Contact Lynsie Thomason
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/21/2019
Decision Date 04/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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