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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K161534
Device Name EasyOne Pro Respiratory Analysis System
Applicant
Ndd Medizintechnik AG
Technoparkstrasse 1
Zurich,  CH 8005
Applicant Contact N/A N/A
Correspondent
Ndd Medical Technologies, Inc.
300 Brickstone Sq.
Suite 604
Andover,  MA  01810
Correspondent Contact JERRY MASIELLO
Regulation Number868.1890
Classification Product Code
BTY  
Date Received06/03/2016
Decision Date 02/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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