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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 K160116
Device Name SpiroScout
Applicant
Ganshorn Medizin Electronic GmbH
Industriestr 6-8
Niederlauer,  DE 97618
Applicant Contact Stefan Ponto
Correspondent
Ganshorn Medizin Electronic GmbH
Industriestr 6-8
Niederlauer,  DE 97618
Correspondent Contact PAUL Dryden
Regulation Number868.1840
Classification Product Code
BZG  
Date Received01/19/2016
Decision Date 10/07/2016
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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