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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K181537
Device Name GLOW800
Applicant
Leica Microsystems (Schweiz) AG
Max Schmidheiny-Strasse 201
Heerbrugg,  CH 9435
Applicant Contact Georges Hakim
Correspondent
Leica Microsystems (Schweiz) AG
Max Schmidheiny-Strasse 201
Heerbrugg,  CH 9435
Correspondent Contact Georges Hakim
Regulation Number892.1600
Classification Product Code
IZI  
Date Received06/11/2018
Decision Date 09/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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