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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 K163127
Device Name bellavista 1000
Applicant
IMTMEDICAL AG
GEWERBESTRASSE 8
BUCHS SG,  CH CH-9470
Applicant Contact BEAT KELLER
Correspondent
PROMEDIC, LLC
24301 WOODSAGE DR.
BONITA SPRINGS,  FL  34134 -2958
Correspondent Contact PAUL DRYDEN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/08/2016
Decision Date 07/31/2017
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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