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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K183364
Device Name Bellavista
Applicant
Imtmedical AG
Gewerbestrasse 8
Buchs SG,  CH 9470
Applicant Contact Beat Keller
Correspondent
Vyaire Medical
26125 N. Riverwoods Blvd.
Mettawa,  IL  60045
Correspondent Contact Colleen Watson
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/04/2018
Decision Date 09/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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