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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K230178
Device Name EasyOne Sky Spirometer
Applicant
Ndd Medizintechnik AG
Technoparkstrasse 1
Zurich,  CH 8005
Applicant Contact Andreas Senn
Correspondent
Ndd Medizintechnik AG
Technoparkstrasse 1
Zurich,  CH 8005
Correspondent Contact Andreas Senn
Regulation Number868.1840
Classification Product Code
BZG  
Date Received01/23/2023
Decision Date 10/19/2023
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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