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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
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