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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K091412
Device Name CLEAN PEAK FLOW METER
Applicant
Viasys Healthcare GmbH
Leibnizstrasse 7
Hoechberg,  DE 97204
Applicant Contact THOMAS RUST
Correspondent
Viasys Healthcare GmbH
Leibnizstrasse 7
Hoechberg,  DE 97204
Correspondent Contact THOMAS RUST
Regulation Number868.1860
Classification Product Code
BZH  
Date Received05/13/2009
Decision Date 08/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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