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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 K052176
Device Name FLOWHANDY ZAN100 USB
Applicant
Zan Messgerate GmbH
908 Main St.
Louisville,  CO  80027
Applicant Contact JIM LEWIS
Correspondent
Zan Messgerate GmbH
908 Main St.
Louisville,  CO  80027
Correspondent Contact JIM LEWIS
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/10/2005
Decision Date 01/12/2006
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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