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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 K982334
Device Name AIRZONE PEAK FLOWMETER
Applicant
CLEMENT CLARKE INTL., LTD.
EDINBURGH WAY
HARLOW,  GB CM20 2TT
Applicant Contact M J WILKINSON
Correspondent
CLEMENT CLARKE INTL., LTD.
EDINBURGH WAY
HARLOW,  GB CM20 2TT
Correspondent Contact M J WILKINSON
Regulation Number868.1860
Classification Product Code
BZH  
Date Received07/02/1998
Decision Date 01/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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