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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 K181524
Device Name Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
Applicant
Vyaire Medical, Inc.
Leibnizstrasse 7
Hoechber,  DE 97204
Applicant Contact Elmar Niedermeyer
Correspondent
Vyaire Medical, Inc.
Leibnizstrasse 7
Hoechber,  DE 97204
Correspondent Contact Elmar Niedermeyer
Regulation Number868.1880
Classification Product Code
BZC  
Subsequent Product Code
DPS  
Date Received06/11/2018
Decision Date 11/30/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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