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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 K141546
Device Name VITALOGRAPH MODEL 7000 SPIROTRAC
Applicant
Vitalograph (Ireland) , Ltd.
Ennis Industrial Estate
Gort Rd. Business Park
Ennis, Co. Clare,  IE
Applicant Contact TOM J HEALY
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number868.1840
Classification Product Code
BZG  
Date Received06/10/2014
Decision Date 09/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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