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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 K142812
Device Name Vitalograph Model 6800 Pneumotrac
Applicant
Vitalograph (Ireland) , Ltd.
Gort Rd. Business Park
Ennis,  IE
Applicant Contact Tom J Healy
Correspondent
Vitalograph (Ireland) , Ltd.
Gort Rd. Business Park
Ennis,  IE
Correspondent Contact Tom J Healy
Regulation Number868.1840
Classification Product Code
BZG  
Date Received09/29/2014
Decision Date 06/29/2015
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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