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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 K042058
Device Name ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN
Applicant
CLEMENT CLARKE INTL., LTD.
EDINBURGH WAY
HARLOW, ESSEX,  GB CM20 2TT
Applicant Contact PHILIP HALLYBONE
Correspondent
CLEMENT CLARKE INTL., LTD.
EDINBURGH WAY
HARLOW, ESSEX,  GB CM20 2TT
Correspondent Contact PHILIP HALLYBONE
Regulation Number868.1840
Classification Product Code
BZG  
Date Received07/30/2004
Decision Date 03/23/2005
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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