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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 K100687
Device Name VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120
Applicant
Vitalograph (Ireland) , Ltd.
Ennis Industrial Estate
Gort Rd. Business Park
Ennis, Co. Clare,  IE
Applicant Contact TOM J HEALY
Correspondent
Vitalograph (Ireland) , Ltd.
Ennis Industrial Estate
Gort Rd. Business Park
Ennis, Co. Clare,  IE
Correspondent Contact TOM J HEALY
Regulation Number868.1840
Classification Product Code
BZG  
Date Received03/10/2010
Decision Date 10/16/2010
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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