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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
Niederlaauer,  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
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