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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 K020004
Device Name CLINDATALINK VERSION 1.0 FOR SPIROMETRY
Applicant
COMPLEWARE CORP.
221 EAST BURLINGTON ST.
IOWA CITY,  IA  52240
Applicant Contact KAY WEILER
Correspondent
COMPLEWARE CORP.
221 EAST BURLINGTON ST.
IOWA CITY,  IA  52240
Correspondent Contact KAY WEILER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received01/02/2002
Decision Date 07/24/2002
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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