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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 K160253
Device Name Vitalograph Model 6300 micro
Applicant
VITALOGRAPH (IRELAND) LTD.
GORT ROAD BUSINESS PARK
ENNIS,  IE V95 HFT4
Applicant Contact TOM J HEALY
Correspondent
VITALOGRAPH (IRELAND) LTD.
GORT ROAD BUSINESS PARK
ENNIS,  IE V95 HFT4
Correspondent Contact TOM J HEALY
Regulation Number868.1840
Classification Product Code
BZG  
Date Received02/01/2016
Decision Date 08/26/2016
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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