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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calculator, pulmonary function data
510(k) Number K183567
Device Name Vyntus/SentrySuite Product Line
Vyaire Medical
Leibnizstrasse 7
Hoechberg,  DE 97204
Applicant Contact Elmar Niedermeyer
Vyaire Medical
Leibnizstrasse 7
Hoechberg,  DE 97204
Correspondent Contact Elmar Niedermeyer
Regulation Number868.1880
Classification Product Code
Subsequent Product Codes
Date Received12/21/2018
Decision Date 08/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No