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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 SQUARE
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
Recalls CDRH Recalls
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